Regulatory Affairs Specialist
Medtronic•Lafayette, CO
About The Position
Medtronic’s Advanced Energy Operating Unit develops technologies for surgical procedures involving vessel sealing and dissection. The Regulatory Affairs Specialist supports medical technologies throughout the product lifecycle by preparing regulatory documentation, assessing product-change impacts, maintaining regulatory systems, and supporting compliance with global requirements. The role partners with cross-functional teams and contributes to regulatory strategy, product development, lifecycle planning, change control, and process improvements.
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 resolve issues, manage priorities, and keep regulatory activities on track.
- Contribute to process improvements and help strengthen regulatory practices across the organization.
Benefits
- Health insurance
- Dental insurance
- Vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Global well-being program
- Incentive plans, including the Medtronic Incentive Plan
- 401(k) plan with 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
Mid Level
