Principal Global Compliance Investigations jobs at Boston Scientific in United States, Marlborough

Responsibilities:

Assist in process optimization projects for the regulatory affairs area (e.g. database maintenance, regulatory controls, automation).
Perform data analysis and report findings.
Process mapping to identify areas for optimization and automation

Requirements

Desirable skills or interests:

skills to clean and preprocess data to ensure its accuracy and consistency;
Interests in programming languages, scripts for task automation, database management

Job Purpose

In Operations, provide daily support of products, processes, materials, and equipment to achieve production goals (i.e., quality, delivery, cost, productivity, and safety).

Key Responsibilities

• Uses problem-solving methodologies to support issue investigations and make improvements.
• Actively interacts with cross-functional team members through face-to-face meetings, virtual video calls, emails or group sessions.
• Practices good teamwork by actively listening, sharing ideas and working together as one team, in support of day-to-day operating requirements.
• Assists in the development and analysis of process, product, material or equipment specifications and performance requirements
• Evaluates new equipment/processes/chemicals for environmental impact to eliminate or lessen such impacts in conjunction with Environmental Health and Safety (EHS)As part of personal development, may assume engineering responsibility for manufacturing equipment or processes within the cleanroom environment.
• Interfaces with vendors, possibly physicians and other technical consultants as part of the role.
• Builds Quality into all aspects of work by maintaining compliance to all quality requirements in Standard Operating Procedures.

Education & Experience

• NFQ Level 8 Honours Bachelor’s degree in a STEM discipline is required. (You must be graduating prior to September 2026 or have graduated in last 2 years)
• An understanding of systems and a willingness to learn and develop technical skills.
• Good communication skills, teamwork abilities and initiative.
• Proven ability to work well as part of a team & on own with minimum supervision.
• Eager to learn and active participate.
• Strong interpersonal skills.

• Eligible to work in Ireland.

• Competitive Benefits –we offer market leading benefits including performance-related bonus, pension contribution, onsite gym, onsite parking, subsidised canteen, organised social groups and healthcare.

• – opportunity to transform the lives of patients worldwide.
• Our Culture- our work is guided by core values that define our culture and empower our employees.
• Career Development– our highly engaged leaders will empower you to grow and will invest in your potential. You can also broaden your skills through personal development courses.
• Opportunity to Innovate– we encourage you to fulfil your true creative potential by speaking up with your ideas and solutions to problems that matter.
• Work-Life Balance– we have created a culture that acknowledges, respects and supports your life and work choices.
• Corporate Social Responsibility– we are dedicated to progressing business practices in areas important to our communities. Our onsite charity events have raised over €1.5 million for worthy causes in the past ten years.

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This is more than a role. It’s a movement.

🌿Carbon Neutrality by 2030Be the architect of our transformation as we drive our major manufacturing and distribution centers toward carbon neutrality—setting a new standard for sustainable innovation.

♻️Design and execute a global zero waste roadmap by 2030, embedding circularity into every layer of our operations.

Who You Are:

• A visionary EHS leader with a track record of driving change across complex global organizations.
• A collaborator, innovator, and strategist who sees challenges as opportunities.
• A purpose-driven professional ready to leave a legacy of impact.

Because here, your work saves lives—and your leadership shapes the future. You’ll join a company that’s committed to doing what’s right for patients, employees, and the planet. And you’ll be part of a team that’s not just talking about change—we’re making it happen.

The position requires strategic vision and hands-on implementation to build world-class EHS performance based on a strong global culture. They work closely with various functions, facilities and geographies to develop, implement and sustain EHS programs, policies and procedures that deliver the required high performance. Such strategies and programs are developed in harmony with the Companies business objectives and are aligned with its growth trajectory. The Snr. EHS Director is responsible for EHS performance at over 20 manufacturing sites and more that 120 commercial locations with a workforce of circa. 60,000. Working closely with a network of 200 EHS and Occupational Health professionals they deliver a vital two-way connection between senior leadership and site operations.

Strategic Leadership:

• Partners with key senior leadership within BSC to ensure EHS strategies are aligned with business needs and EHS challenges are communicated upwards.
• Delivers strong leadership within the EHS community across all geographical regions establishing common purpose and focus on key performance.
• Exhibits the leadership qualities of trust, integrity, courage, clear communication and loyalty in all personal actions and ensures they are fostered in the broader EHS community.
• Ensures visible and impactful EHS leadership to the broader business stakeholders.
• Understands the leadership challenges of others to facilitate the necessary partnerships for effective EHS management.
• Builds and develops an EHS staff that has the skills, competencies and abilities to meet the current and future needs of the Company at both a global and local level.

Strategy and AOP:

• Develops a Global EHS strategy that delivers the required EHS performance while supporting the company business needs.
• Ensure Global strategy is cascaded into all levels of the organization, is embedded in local strategies and monitored to ensure effective delivery.
• Create and maintain a process for local EHS issues and challenges to be communicated to Global EHS, enabling their inclusion in the global strategies where necessary.
• Achieve senior leadership agreement with the EHS strategy to drive successful outcomes.
• Envisions potential challenges 5 to 10 years out and builds protective strategies, processes and structures to protect the business and enable its continued unhindered development.

EHS Operational Excellence:

• Ensures compliance to the Global EHS policy and enhances implementation by providing core operational guidance for all the locations and regions.
• Ensures all manufacturing and Tier I Distribution locations are certified to ISO14001: Environmental Management Standard and the ISO45001: Health and Safety management standard.
• Identifies and ensures the development of Global Standards for key EHS programs, oversees their deployment and ensures verification of effectiveness.
• Delivers and maintains EHS digital platforms that enables global connectivity across all key programs, communicates real-time performance and enables early flagging of emerging challenges.
• Deliver impactful risk control and risk mitigation through structures risk analysis and problem-solving techniques.
• Ensures EHS risk-informed strategies are in place for key operational aspects, spanning Global Supply Chain, Commercial activities and Acquisitions & Integrations.

Compliance Assurance:

• Ensures the Company is aware of, and compliant to, all EHS regulatory requirements at local, regional and global level by maintaining an effective compliance assurance program.
• Delivers surveillance of pending EHS regulations, globally, regionally and locally, which enables early response. Maintains the company EHS compliant while ensuring the Company business needs are advocated for.
• Represents the Company within relevant trade associations, professional bodies and industry groupings on EHS topics relevant to the Company.

Occupational Health:

• Oversees a Global Occupational Health service that focuses on employee health, medical accommodations, return to work and employee wellness; supporting both the employee and the business.
• Ensures occupational health support services are available for all employees globally and emergency advice contacts are in place.
• Ensure the development and upskilling of the global Occupational Health Nurses is supported to maintain required competencies as new requirements emerge.

Performance:

• Establishes key EHS performance targets for Environment, Health and Safety across the entire organization that drive meaningful continuous improvement while aligned to the needs and abilities of the business, both globally and locally.
• Maintains a live tracking and reporting process for delivery of the agreed EHS performance targets with escalation and reaction mechanisms where needed.
• Ensures positive performances are recognized and celebrated.
• Establishes a positive EHS performance culture where delivery of EHS goals, both within the function and across other functions, is the norm.

Acquisitions and Integrations:

• Ensures availability and provision of EHS supports to Acquisition and Integration teams for Due Diligence, EHS Criticality assessments, gap assessments, integration plans and resourcing planning.
• Ensures acquisition Integrations are supported and actively facilitated as they adapt to the new BSC culture, programs and operational requirements.

Required Qualifications:

• Bachelor’s degree required preferably within Environmental Sciences or in an engineering discipline.
• 10+years of EH&S experience to include standard concepts, practices, and procedures within the EH&S field.
• 5+ years of people leadership experience, ability to guide, coach, direct, and develop direct reports, and drive those practices throughout their organization.
• Experience in controlling the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
• Proven ability to work through other functions and personnel to deliver on EHS goals while supporting the business locally and globally.
• Demonstrated experience collaborating with global business partners, building inclusive partnerships and valuing diversity across cultures and regions.
• Strong communication and presentation skills required, with ability to influence and drive new ideas at the executive level.
• Self-starter with high degree of latitude is required.
• This role requires travel domestic and international to BSC global locations.

Preferred Qualifications:

• MS or MBA preferred
• Global, multi-site experience is strongly preferred
• Medical Devices industry experience

Maximum Salary: $ 327800

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

About the role:

This role requires a high-level view of the product under development and its interactions with other sub-systems within its use environment. It is critical to understand the impact that one sub-system can have on the overall system and how changes within a sub-system can propagate changes in other parts of the system.

Your responsibilities will include:

• Fully participate in and successfully contribute to project teams either as an individual contributor or technical leader
• Able to design and develop high-level system architecture.
• Develop system and subsystem-level requirements.
• Work independently to plan and schedule R&D activities necessary to meet timelines.
• Design and coordinate engineering tests and experiments.
• Perform troubleshooting on systems related to design, interactions with other sub-systems, materials, or processes.
• Summarize, analyze, and draw conclusions from test results. Be able to run basic statistical models to analyze data.
• Prepare standard reports/documentation to communicate results to the technical community.
• Responsible for engineering documentation.
• Work cooperatively with outside vendors, quality, regulatory, clinical, and marketing teams to ensure project success.

Required qualifications:

• BS/MS in Biomedical, Biomaterial, Mechanical, or Systems Engineering.
• 6+ years of engineering experience with medical devices.
• Experience with troubleshooting medical systems.
• Proven self-starter with a strong track record of technical leadership and the ability to work independently to plan, schedule, lead, and execute tasks necessary to meet project deadlines.
• Experience with systems architecture, design and development.
• Experienced in testing, system and subsystem requirements preparation, test method development, design verification, and validation.
• Hands-on approach to problem-solving.

Preferred qualifications:

• A Biomaterial Engineering background is strongly preferred.
• Medical device systems product development experience.
• Strong communication skills (verbal and written).
• Proven technical leadership of prior projects.

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.

About the role:

The GRC Manager will work as part of a broad, global team within the Global Quality system and particularly with all site and divisional Quality leadership to identify any gaps in compliance with internal and external requirements.

The Global Regulatory Compliance Manager will create a culture of compliance and facilitate adherence to the BSC Quality System and all appropriate regulations that BSC follows. They will ensure appropriate quality system processes are created, maintained, and followed in support of Corporate and Site quality objectives.

Your responsibilities will include:

• Manage, coach, and develop a team of quality system auditors that execute both the Corporate audit schedule as well as a global risk-based audit schedule.
• Partner with Quality leaders across the BSC network (sites, divisions, and regions) to ensure a high level of compliance by developing and deploying a data-driven, risk-based audit schedule.

• Support the audit team in identifying and documenting significant quality system nonconformances against external regulations and internal SOPs/WIs.
• Act as the sub-process steward for the global Internal Audit process.
• Lead the development and ownership of the strategic process roadmap as well as ownership of the internal audit community of practice.
• Implement auditor training, technical tools and drive continuous improvement and efficiencies to support a preventive quality culture.
• Review and assess changes to standards and regulations applicable to the assigned area for potential impact to BSC and initiate projects, as needed, to ensure continued compliance.
• Facilitate external audits through leadership in audit front rooms, back rooms, training for SME’s, creation of storyboard material and site level support for Global procedures.

• Deliver process improvements through the VIP model with year over year savings against a multimillion-dollar yearly goal.

• Act as a CAPA owner for corrective actions necessary to improve the global processes.
• Champion departmental or cross-functional quality initiatives.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Required qualifications:

• Minimum of Bachelor’s degree in relevant field
• Minimum of 10 years of Medical Device Quality Systems experience including extensive experience auditing
• Understanding of regulations and standards applicable to the BSC Global Quality System (ISO 13485, 21 CFR 820, EU MDR, etc.).
• Demonstrated inclusive leadership skills
• High degree of integrity, professionalism, and the ability to establish credibility internally and externally
• High sense of urgency and commitment to execution
• Ability to travel up to 25 - 30% domestically and internationally

Preferred qualifications:

• Advanced degree
• Pharmaceutical experience
• Digital product ownership and/or IT project experience
• Strong analytical and communication skills

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

About This Role:

Principal Statistician, you will play a pivotal role in shaping the future of innovation at Boston Scientific. You will provide technical and statistical leadership that empowers teams within Endoscopy and across our global network to deliver breakthrough solutions. Your expertise will be instrumental in driving new product development from concept to launch, ensuring that every decision is grounded in robust data and statistical insight.

You will be a key mentor and trusted advisor, not only for our R&D organization but also for cross-functional teams worldwide. By fostering a culture of learning and continuous improvement, you will elevate the statistical & problem solving acumen of engineers, scientists, and technical professionals, helping them translate complex data into actionable strategies that accelerate product development.

Most importantly, your work will directly contribute to launching innovative products that advance patient care. By guiding teams through the rigorous application of statistical methods, you will help ensure our products meet the highest standards of quality and safety to make a tangible difference in the lives of patients around the world.

Your responsibilities will include:

• Provide statistical expertise and support to R&D using statistical methods associated with product and process development, design assurance, and problem-solving in root cause investigations.
• Interpret data and provide insight on the underlying factors driving the results to advise engineers on the best strategies to move forward, not just on the data analysis
• Apply a variety of statistical analyses and techniques to data generated by R&D, Process Development, and other technical groups.
• Create and maintain statistics-related procedures and tools for the Marlborough site and the global network.
• Collaborate with Global Statisticians and cross-functional teams working towards continual improvement of the application and use of statistics across various projects and business initiatives.
• Identify and lead projects that improve efficiencies in product and process development through designed experiments, reduced sampling methodologies, and advanced or automated data analysis.
• Provide feedback to cross-functional development teams during design reviews on the application and insights from statistical analysis tools.
• Develop and deliver training (classroom and virtual options) on the appropriate use of statistical methods with R&D, Process Development, and other technical groups.
• Perform ad hoc statistical analyses and provide guidance as required.
• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.

Required qualifications:

• Bachelor's degree in Mathematics, Statistics, Physics, or Engineering
• 8+ years' experience in an industry role, preferably within medical devices; experience in a regulated environment is required
• 5+ years' experience using Minitab, Design Expert, or other relevant statistical software
• Proven ability to apply statistical analysis in a professional setting; highly self-motivated and results-driven

Preferred qualifications:

• Master’s or PhD in Mathematics, Statistics, Engineering, or a related field
• Experience working in or closely with R&D or Development Engineering teams
• Demonstrated application of statistical tools to support project deliverables (e.g., test method validation, design verification testing)
• Six Sigma Black Belt or Master Black Belt certification

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions:It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Spencer Gregory Hale

Serves as a Global Risk Management process owner to drive and support Global Risk Management initiatives and quality goals and priorities. Develops, establishes, and maintains global processes, systems, and practices that meet BSC, customer, and regulatory requirements. Partners with design teams across all divisions and leads global communities of practice (CoP) to drive and improve BSC’s Global Risk Management process, in collaboration with the global risk management sub-process stewards.

Your responsibilities include:

• Demonstrating competence in drafting, editing, and implementing effective Global Risk Management procedures with input from all divisions to support the development and maintenance of products to meet or exceed internal and external requirements.
• Acting on feedback trends identified through QS audit, product submissions, and QMR metrics by driving process improvement projects across the Risk Management Sub-Process.
• Influencing key stakeholders through collaborative community engagement. Helping connect the key SMEs across divisions and capitalizing on networking skills to promote best practice sharing and efficient problem solving.
• Partnering with all upstream and downstream process owners to ensure the right linkages with the Global Risk management Process are maintained (i.e., production and process controls, material controls, post-market support)
• Supporting internal and external audits and audit responses for existing products.
• Monitoring compliance with company policies and procedures.
• Owning Global CAPAs, including proven experience with complex, multi-site/multi-division problem-solving.
• Acting as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Ensuring the development and execution of streamlined business processes which help achieve VIP/Continuous Improvement goals.

Require Qualifications:

• Bachelor's degree in Science, Health, or Engineering.
• Minimum of 5 years of Medical Device Design Controls and Risk Management experience required.
• Understanding of US and International regulations including 21 CFR Part 820, ISO 13485, and EN ISO 14971 is required, as well as knowledge of the Medical Device Directive and EU MDR.

Preferred Qualifications:

• Excellent oral and written communication skills (e.g., giving presentations to peer groups and various levels of management, sharing clear and concise information, managing change effectively using a variety of communication methods and tools, etc.).
• Advanced project management skills (e.g., breaking projects into smaller tasks, coordinating work with other impacted process or document owners, balancing competing priorities, managing expectations on project timelines, etc.).
• Expertise in Microsoft Office Suite programs including, Teams, Excel, PowerPoint, and Word.

Maximum Salary: $ 164500

Compensation fornon-exempt (hourly), non-sales rolesmay also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation forexempt, non-sales rolesmay also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.