Prin Regulatory Affairs Spec - Core Surgical innovations
About The Position
Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact. A Day in the Life The Principal Regulatory Affairs Specialist develops and executes strategies for global regulatory approvals to introduce new and modified medical device products to the market. The Principal Regulatory Affairs Specialist translates regulatory requirements into project/product requirements, prepares worldwide regulatory submissions and negotiates their approval. Responsibilities include participating on product development teams, developing global regulatory strategies, preparing US and international regulatory submissions, supporting pre and post market regulatory compliance activities and evaluating proposed product changes for regulatory impact and preparing necessary documentation.
Requirements
- Minimum Requirements Bachelors degree with 7+ years of regulatory affairs experience OR An advanced degree with 5+ years of regulatory affairs experience
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Nice To Haves
- 7+ years of medical device regulatory affairs with roles showing increasing responsibility
- Experience with FDA requirements, guidance documents, Medical Device Directive (93/42/EEC), Medical Device Regulation (EU 2017/745), ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
- Strong leadership and team management skills.
- Excellent communication and interpersonal skills.
- Ability to thrive in a fast-paced, collaborative environment.
- Strong problem-solving and decision-making abilities.
- Experience with Notified Body audits.
- Collaboration and leadership skills in team setting including ability to coach and develop team members, and effective resource management to address multiple priorities.
- RAC credential preferred
- Strong interpersonal, analytical, writing, and organizational skills, including ability to “navigate the grey”
- Ability to analyze and resolve non-routine regulatory issues using independent judgment
- Good understanding of product development process and design control through knowledge of US FDA and international medical device regulations
- Demonstrated history of successful regulatory submissions in the US and EU
- Experience with software-enabled medical devices, including artificial intelligence and machine learning technologies, as well as clinical trials and preclinical testing.
Responsibilities
- Develop and implement comprehensive global regulatory strategies for medical device submissions to ensure timely market access for New Product Development
- Author regulatory submissions, including but not limited to pre-submissions, premarket notifications (510(k)s), EU change notifications, and technical documentation.
- Serve as a key regulatory representative on cross-functional product development teams, providing strategic input, timelines, and direction.
- Review and approve product labeling, training materials, promotional content, and advertising for regulatory compliance.
- Support global pre-market and post-market regulatory activities to maintain product approval and lifecycle compliance.
- Oversee and coordinate multiple regulatory projects across domestic and international markets.
- Provide strategic leadership and mentorship to Regulatory Affairs Specialists in the development of regulatory submissions and interpretation of global regulations.
- Lead or coordinate the preparation of regulatory submission documentation, as well as internal audit and inspection readiness activities.
- Recommend and implement changes to labeling, manufacturing processes, marketing strategies, and clinical protocols to ensure regulatory compliance.
- Monitor and enhance regulatory tracking and control systems to drive process efficiency and documentation integrity.
- Maintain up-to-date knowledge of evolving global regulatory requirements, guidance, and industry best practices.
- Interface with regulatory authorities as required on defined matters, ensuring effective communication and resolution of issues.
- Actively participate in internal and external audits, providing subject matter expertise as needed.
- Review of promotional and advertising material.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
