Regulatory Affairs Specialist
About The Position
Medtronic’s Advanced Energy Operating Unit develops technologies for surgical procedures involving vessel sealing and dissection. The Regulatory Affairs Specialist supports these medical technologies throughout the product lifecycle, partnering with cross-functional teams to prepare regulatory documentation, assess product changes, maintain regulatory systems, and support compliance with global requirements. The role involves communicating regulatory requirements, contributing regulatory input to product development and lifecycle activities, and helping keep regulatory deliverables on track. It is suited to a collaborative professional comfortable navigating complex regulatory requirements and supporting technologies intended to improve patient care.
Requirements
- Bachelor’s degree required.
- Minimum of 2 years of relevant experience, or an advanced degree with a minimum of 0 years of relevant experience.
- For baccalaureate degrees earned outside 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
- Experience with U.S. FDA and international regulatory requirements for medical devices.
- Familiarity with EU MDR, MDD, ISO 13485, ISO 14971, and related standards.
- Experience supporting regulatory submissions, audits, or inspections.
- Strong written and verbal communication skills.
- Strong organizational skills and ability to manage multiple priorities.
- Experience collaborating in a cross-functional, fast-paced environment.
- Familiarity with medical device product development or lifecycle management.
- RAC certification or progress toward certification.
- Experience working with Notified Bodies or global regulatory agencies.
Responsibilities
- Partner with multidisciplinary teams to communicate regulatory requirements and support regulatory strategy.
- Provide regulatory input to product development, lifecycle planning, and change control activities.
- Assess the regulatory impact of proposed design, labeling, manufacturing, and process changes.
- Prepare, review, and coordinate documentation for regulatory submissions, renewals, registrations, and related filings.
- Support audits, inspections, and regulatory authority interactions as needed.
- Participate in risk management activities and help ensure regulatory considerations are addressed appropriately.
- Monitor and support tracking systems used to manage regulatory deliverables and documentation.
- Stay current on applicable regulations, standards, and guidance documents relevant to assigned products and markets.
- Collaborate with internal stakeholders to help resolve issues, manage priorities, and keep regulatory activities on track.
- Contribute to process improvements and help strengthen regulatory practices across the organization.
Benefits
- Competitive salary and flexible benefits package.
- Short-term incentive through the Medtronic Incentive Plan (MIP).
- Health, dental, and vision insurance (for eligible regular employees working 20 or more hours per week).
- Health Savings Account and Healthcare Flexible Spending Account (for eligible regular employees working 20 or more hours per week).
- Life insurance and long-term disability leave (for eligible regular employees working 20 or more hours per week).
- Dependent daycare spending account (for eligible regular employees working 20 or more hours per week).
- Tuition assistance or reimbursement (for eligible regular employees working 20 or more hours per week).
- Simple Steps global well-being program (for eligible regular employees working 20 or more hours per week).
- Incentive plans for regular employees.
- 401(k) plan with employer contribution and match for regular employees.
- Short-term disability and paid time off for regular employees.
- Paid holidays for regular employees.
- Employee Stock Purchase Plan for regular employees.
- Employee Assistance Program for regular employees.
- Non-qualified Retirement Plan Supplement, subject to IRS earning minimums, for regular employees.
- Capital Accumulation Plan for Vice Presidents and above, or subject to IRS earning minimums.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
