Overview Join Medtronic as Principal Regulatory Affairs Specialist to drive regulatory strategy for the Wound Management portfolio from opportunity through commercialization. You will lead US and EU compliance and coordinate with international teams to support global submissions. You will review labeling, advertising, and technical documentation to maintain compliance and enable timely product launches. This role suits experienced regulatory professionals who balance strategic guidance with hands-on submission work and cross-functional collaboration. You will contribute to healthcare innovation at scale, shaping products that improve patient outcomes.
Compensation / Benefits- Health, Dental and vision insurance
- Health Savings Account
- Tuition assistance/reimbursement
- Employee Stock Purchase Plan
- 401(k) plan plus employer contribution and match
- Paid time off
Responsibilities- Provide regulatory affairs domain expertise across the Wound Management device portfolio
- Guide regulatory requirements for new technologies and product modifications (domestic and international)
- Prepare Pre-Sub and 510(k) submissions and CE mark documentation
- Engage with regulatory authorities during development and review
- Communicate regulatory information to international regulatory team and business units
- Support international product registrations as needed
- Manage multiple projects with prioritization to meet schedules
- Collaborate with engineering, quality, clinical, and marketing functions
- Review promotional and advertising materials
- Maintain current regulatory knowledge and update departmental procedures
- Participate in audits and maintain regulatory documentation
Key requirements- Bachelor's degree
- Minimum of 7 years of relevant experience, or 5 years with advanced degree
- Experience with FDA clearance/510(k) and regulatory submissions
- Experience interacting with FDA
- Familiarity with medical device regulatory lifecycle management
- cross-functional collaboration
- regulatory strategic thinking
- attention to detail
- FDA 510(k) submissions
- CE marking process
- regulatory documentation maintenance
