Regulatory Affairs Specialist jobs in United States, Minnesota, Minnetonka

Spencer Gregory Hale

Your responsibilities will include:

• Drives improvement and corrective action in the quality of components sourced from outside suppliers.

• Provides technical support in the selection of suppliers and develops acceptance criteria for materials.

• Monitors supplier performance to drive supplier corrective action, manufacturing yield issues and field failures.

• Assess suppliers for technical, quality and manufacturing capabilities.

• Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.

• Plans and organizes non-routine tasks with approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.

• Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approaches to solutions. Interprets, executes, and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.

• Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. Interacts with suppliers. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represent a specialized field in larger project teams. Influences middle management on business solutions.

• Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the Quality Policy. Establishes and promotes a work environment that supports the Quality Policy and Quality System.

What we're looking for in you:
Minimum requirements:

• BS degree in Mechanical Engineering, Materials Engineering, Chemical Engineering, Electrical Engineering, or similar technical degree with 2+ years related experience.

• Ability to travel up to 10% of the time.

Preferred Qualifications:

• Mechanical or Electrical Engineering background preferred.

• Experience in working with mechanical, electrical, or chemical component suppliers

• Experience working in the Medical Device industry

• Experience with manufacturing support or process development

• Experience with auditing quality systems or ISO13485, 9001, TS16949 standards

• Experience in lean and six sigma methodologies

• Experience with project management

Maximum Salary: $ 132000

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.

About this Role:

As a Principal Performance Improvement specialist you will support the Urology division, serving as a strategic resource to lead cross-functional performance Improvement projects, and drive the development of a sustainable, agile, high-performance culture. In this role, you will work with Urology divisional and functional leaders and stakeholders to drive improvement in key processes and systems and identify and support productivity opportunities across the Urology franchises.

Your Responsibilities will Include:

• Partner with leadership to develop performance improvement strategies, goals, and execution plans.
• Identify, develop and execute performance improvement programs and projects utilizing structured problem-solving methodologies. Perform or coach charter creation and scoping, root cause analysis, solution development and program plan roadmaps. Facilitate workshops for small and large teams.
• Champion / assist or lead change management efforts for programs and projects within your responsibility
• Contribute to, design and/or provide training on structured problem-solving methodologies.
• Assist with coaching performance improvement projects lead by others as needed across the division
• Collaborate with leaders and their organization/function to inspire a continuous improvement culture by deploying process improvement/operational excellence roadmaps, methods, and tools across the business.
• Influence key stakeholders to engage and participate in improvement activities essential to process and system improvement.
• Partner with leaders, champions, and employees to share best practices to further accelerate the rate of improvement.

What we’re looking for in you:

• Demonstrated history of successful performance improvement leadership and execution across multiple projects
• Passion for both the technical process of problem-solving and the people side of change
• Comfort in gray spaces and dealing with ambiguity
• Strong analytical acumen with the ability to make a significant contribution to performance improvement
• Self-starter and entrepreneurial/consultant mindset
• Ability to build enthusiasm for change
• Strong interpersonal communication and presentation skills

Requirements:

• 5+ years of Lean/Six Sigma/Continuous Improvement related experience
• BS/BA Degree in Engineering/Business or related field, Advanced degree preferred
• Certification in standard problem-solving methodologies
• Domestic and international travel of about 10%

Highly Preferred Requirements:

• Black Belt / Master Black Belt Certifications in Lean / Six Sigma and Project Management preferred
• Medical Device experience or experience in a highly regulated industry

Preferred Requirement:

• Experience in developing and/or delivering standardized problem-solving training
• Change management certification, or experience in applying change management principles
• Project Management / PMP 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.

About the role:

This is a hybrid position (in office minimum three days per week) with the flexibility to be located in Marlborough, MA, or Arden Hills, Maple Grove or Minnetonka, MN. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Your responsibilities will include:

• Coordinate, compile, and submit US and EU regulatory filings for new and modified products, including PMAs, PMA supplements, pre-submissions, 510(k)s, annual reports, and MDR CE mark submissions
• Develops and implements regulatory strategies for new and modified products
• Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, commercialization, and coordinating team inputs for submissions
• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams, monitors proposed and current US and EU regulations and guidance and advises on the impact of such regulations
• Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations
• Tracks timelines and documents milestone achievements for inclusion in regulatory submissions
• Interacts with regulatory agencies as part of submission review and on-site audit support
• Reviews device labeling for compliance with global regulations; analyzes and recommends appropriate changes
• Trains to departmental and divisional policies and procedures
• Fosters a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility

Required qualifications:

• A minimum of a Bachelor’s degree, preferably in a scientific or technical discipline
• A minimum of 4 years work experience in Regulatory Affairs or a related discipline (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in medical devices or drugs
• Demonstrated knowledge of FDA, EU and/or international regulations
• Demonstrated experience supporting product development and sustaining activities
• Prior experience with a variety of submission types (DeNovo, 510(k), PMA, EU MDR)
• Experience of regulations applicable to the conduct of clinical trials
• Demonstrated understanding of product development process and design controls
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms)

Preferred qualifications:

• Medical electrical equipment (MEE) experience
• Implantable medical device experience
• Ability to manage several projects simultaneously
• Effective research and analytical skills
• Excellent written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision

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 the role:
The Senior Clinical Safety Specialist manages adverse event, device reporting, and safety deliverables for investigational and marketed products in the Urology division. This position is responsible for authoring and ensuring execution of project-specific safety plans as well as overseeing event and complaint processing in accordance with study-specific operational plans.

This is a hybrid position (in office minimum three days per week) with the flexibility to be in Maple Grove, MN or Marlborough, MA or Valencia, CA. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Your responsibilities will include:
⦁ Manage adverse event processing including report review, safety query management, and expedited reporting

⦁ Assess type/level of processing to be done for adverse events

⦁ Minimum bachelor’s degree or equivalent experience
⦁ Minimum 5 years clinical trial experience within role of safety
⦁ Proven or prior experience with clinical trial safety

⦁ Therapeutic knowledge in Urology
⦁ Knowledge of GCP
⦁ Experience with processing and assessing safety events and medical narrative writing
⦁ Clinical database and systems

Maximum Salary: $ 152200

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.