Regulatory Affairs Specialist

Medtronic • Lafayette, CO

1d

About The Position

Medtronic’s Access and Instruments Operating Unit develops technologies that support surgical access and enable precise, efficient procedures across a range of care settings. As a Regulatory Affairs Specialist, you will support innovative medical technologies throughout the product lifecycle by partnering with cross-functional teams, preparing regulatory documentation, assessing product-change impacts, maintaining regulatory systems, and helping ensure compliance with global requirements. The role involves navigating complex regulatory requirements while 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 satisfying 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 the 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

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level