Senior Regulatory Affairs Specialist jobs at Boston Scientific in United States, Santa Clarita

This is a defined term position with an expected duration of 1 year.

Your responsibilities will include:

• Identifying the opportunities for continuous improvement and initiates activities to support the improvement process.
• Leading quality projects of major magnitude and scope.
• Providing significant guidance and approval regarding technical strategies and approaches.
• Managing and providing direction to quality engineers on professional, personnel issues, and provides development opportunities.
• Providing guidance and training to staff, assists subordinates in attaining career goals, motivates individuals to achieve results, and recruits and maintains a high quality staff.
• Participating on team projects and assignments, facilitating or leading teams as necessary.
• Determining project staff assignments and schedules work to meet completion dates and deliverables.
• Working cross-functionally in identifying and resolving technical issues.
• Driving and evaluates project and department progress and results.
• Providing guidance and decisions on Operations and Design Control activities to ensure continued compliance with internal BSC procedures, and applicable regulatory and international standards as defined in the BSC Quality Policy and site Compliance Matrix.

Required qualifications:

• Bachelor degree
• Minimum of 7 years experience in medical device or similar regulated industry
• Minimumof 4 years leading cross functional teams in a technical field
• Able to travel 1-2 times a year

Preferred qualifications:

• More than 10 year of experience in Medical Devices or similar regulated industry
• Higher education MBA, MS in science or engineering
• Neuromodulation device experience, capital equipment experience
• Experience working with TUV, BSI, FDA etc
• Boston Scientific experience

Maximum Salary: $ 243000

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:

We are seeking a highly skilledwith expertise and focus on creating innovative firmware solutions for medical devices. As a Senior Manager, you will play a key role in leading a team of embedded software engineers that design, develop, and maintain critical firmware applications that drive the functionality of implantable medical devices, ensuring compliance with industry regulations and standards.

Your responsibilities will include:

• Managing the team to execute programs in line with short and long term strategic vision for technologies, indications, research, use models and intellectual property for BSC products and services.
• Align, represent, communicate and guide the team to execute Corporate, Divisional and Functional mission, vision, goals and values.
• Manage team to perform according to best practices within functional area of expertise, keeping a high standard of executional excellence.
• Plan, manage, hire and assign resources to projects.
• Drive technical projects of major magnitude and scope, by coordinating with the project managers/core team leaders.
• Function as reviewer for technical solutions, source code, architecture designs, etc.

Required Qualifications:

• Bachelor’s or Master’s degree in an engineering field including (but not limited to) software engineering, computer science, electrical or electronic engineering.
• 6+ years of experience in software development.
• 3+ years of experience leading engineers, as manager or technical leader.
• Proven experience in a regulated industry.

Preferred Qualifications:

• Master’s degree in Electrical or Electronic Engineering.
• 10+ years of experience, including a significant portion of it managing embedded firmware teams.
• Proven experience in the Medical Device Industry. Familiarity with IEC62304 and IEC60601.
• Experience with C/C++ in a microcontroller environment.
• Excellent written and verbal communication skills.
• Experience working with multinational teams, external contractors and consultants.

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.

Your responsibilities will include:

● Own the product vision, strategy, and roadmap for divisional AI initiatives that enable incremental revenue and improve productivity across field and back-office functions (e.g., AI-enabled pre-authorization, sales rep next best actions, and customer-facing chatbots). Provide consistent progress updates to leadership and monitor KPIs aligned with business strategy.

● Partner with change enablement teams to ensure successful adoption through effective communication, training, and change management.

● Lead AI upskilling initiatives across field, internal, and leadership teams to increase productivity and awareness of AI tools and applications.

● Collaborate across divisional functions to create and maintain a cross-functional AI roadmap.

● Establish and execute divisional AI governance and operating models, including intake, prioritization, and acceleration frameworks through divisional councils and corporate teams.

● Support discovery, assessment, prioritization, and development of commercial capabilities such as CRM, eCommerce, and sales quoting solutions to support Revenue Enablement.

● Drive discovery and planning sessions with business stakeholders, ensuring alignment and actionable roadmaps.

● Partner cross-functionally with Product Managers, Product Owners, Business Analysts, and Developers to ensure cohesive delivery.

● Execute initiatives to improve KPIs and ROI through analytics, dashboards, and actionable insights.

● Promote a positive, agile team culture and facilitate open communication across all levels.

● Stay informed on revenue enablement technologies, clinical workflows, and system integrations.

● Bachelor’s degree in Business Administration, Management, Marketing, Computer Science, or related technical field.

● Minimum of 5 years' experience in product management or product design focused on software products and technologies.

● Strong working knowledge and/or prior implementation experience of AI use cases in commercial or back-office functions.

● Familiarity with large language models (LLMs), AI agents, prompt engineering, and enterprise AI applications.

● Experience collaborating with AI platform and engineering teams on GenAI, AI/ML, and data products.

● Proven program management experience standing up governance models, operating frameworks, and business case/value creation processes.

● Demonstrated cross-functional influence and ability to communicate across all organizational levels, including senior leadership.

● Proficiency in commercial enterprise systems, processes, and data flows, ideally within Commercial Excellence, Revenue Operations, or Digital Enablement.

● Strong analytical, problem-solving, and strategic thinking skills.

● Ability to deliver innovative, customer-centric, technology-driven solutions.

● Proficiency in modern software development methodologies (agile, test-driven development, CI/CD).

● Proven experience developing and evolving product strategies based on data and industry trends.

● Ability to manage multiple priorities effectively in a fast-paced environment.

● Willingness to travel up to 15%.

● Advanced degree (MBA).
● Current or previous Boston Scientific experience.
● Experience with Neuromodulation or the broader MedTech/life sciences industry.
● Background in Sales Operations, Marketing, or Digital Enablement.
● Prior experience leading AI upskilling initiatives within an organization.

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.

Your responsibilities will Include:

• Support detailed project planning in support of major project, product/process transfer etc.
• Co-coordinating the activities of any BSC allocated project resources.
• Support the PM to identify and manage project dependencies and critical path items while ensuring project quality and utilizing and following appropriate methodologies.
• Development of and adherence to project contract or terms and conditions.
• Liaise with project manager, other team members, and functional management as necessary and effectively communicates project expectations and deliverables to team members in a timely and clear fashion.
• Development and implementation of appropriate supporting documentation and project management tools (meeting notes, decision log, risk matrix, Terms and Conditions)
• Prepare project status updates
• Support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support.
• Identify and escalate unresolved obstacles to the success of the project.
• Participates in the planning, execution, and finalization of projects according to strict deadlines, within budget, and by following organized and repeatable procedures.
• Conducts project post mortems and communicates lessons learned in order to identify successful and unsuccessful project elements.
• Use critical thinking to offer new ideas and potential improvements to the project plan

Required qualifications:

• 3+ years related experience to include leading or managing projects
• 2 yrs experience in data management and technology systems implementation
• Strong data analysis skills
• Strong familiarity with Microsoft Tools and ability to learn software quickly
• Concise verbal and writing communication

Preferred qualifications:

• 3+ years medical device industry experience
• Preferred experience in process development and leading continuous improvement
• Experience in creating & facilitating communication to stakeholders
• Bachelor’s degree

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.

Your responsibilities will include:

● Serve as the primary relationship holder and trusted advisor for NM85 economic customers within GPOs, IDNs, MSOs, ASCs, and other national and strategic accounts.

● Collaborate with IVS regional business directors (RBDs), area vice presidents (AVPs), Marketing, and Franchise Leaders to develop aligned national account strategies and objectives.

● Develop and implement cross-portfolio contracting strategies in partnership with NMD colleagues to grow the IVS and broader Pain franchises.

● Maintain a deep understanding of the U.S. market, including customer operations, financials, and strategic imperatives. Identify and prioritize key accounts for growth and business protection.

● Build strong, sustainable relationships with key influencers and decision-makers. Understand their strategic priorities to develop tailored solutions.

● Manage contracts and develop transformational new business offerings that are strategically significant and differentiated within the market.

● Partner cross-functionally with internal stakeholders to ensure excellence in account execution and service delivery. Act as a key contact for other NMD franchises, focusing on IVS.

● Stay current on industry trends, competitor actions, and market shifts. Collaborate with Health Economics to anticipate market dynamics and leverage funding opportunities.

● Promote a collaborative, high-performance environment, sharing insights and fostering innovation within the team.

● Coach and mentor team members to enhance professional development and effectiveness.

● Bachelor’s degree in Business, Marketing, or related field.
● Minimum of 10 years' experience in national accounts, healthcare contracting, or related roles within the medical device or healthcare industry.
● Proven success developing and executing commercial strategies across multiple customer segments (GPOs, IDNs, MSOs, ASCs).
● Demonstrated ability to lead complex negotiations and develop innovative contracting solutions.
● Strong cross-functional leadership and collaboration skills.

Preferred qualifications:
● MBA or advanced degree preferred.
● Experience managing P&L or business unit budgets.
● In-depth understanding of the U.S. healthcare reimbursement landscape and health economics principles.
● Excellent strategic thinking, problem-solving, and communication skills.

The anticipated annualized base amount or range for this full time position will be$ to $, plus variable compensation governed by the Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives) as well as the value of core and optional benefits offered at BSC, which can be reviewed at www.bscbenefitsconnect.com. Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.

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 testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

Your responsibilities include:

• Perform all aspects of the monthly financial close including generation of monthly and quarterly management reporting and variance/trend analysis
• Supports the annual planning process for the functional areas of responsibility including coordinating with the various functional groups to develop operating expense budgets and providing analytical support to identify key business drivers
• Analysis and submission of functional budgets
• Support decision-making process to enable profitable growth
• Support regular and adhoc reporting and presentations to management
• Identify and drive cost saving opportunities across the SG&A functions
• Quickly respond to numerous ad hoc queries from internal customers (including Senior Management)

Minimum Qualifications:

• Bachelor’s degree in Finance or Accounting
• 5+ years of relevant FP&A experience
• MS Excel and PowerPoint required, financial tools (Hyperion (Oracle), SAP) preferred
• Excellent oral and written communication skills
• Strong financial analysis, communication, organizational and prioritization skills
• Strong attention to detail and data accuracy

Preferred Qualifications:

• Ability to multi-task and set priorities/execute in a high-paced organization
• Ability to work in a dynamic environment, adhere to tight deadlines
• Team orientated
• Must have a process improvement mindset and strong problem-solving 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.

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.