Regulatory Affairs Specialist
Medtronic Inc
Medtronic seeks a Regulatory Affairs Specialist to support international regulatory strategies and product submissions across global markets. The role coordinates documentation, manages compliance activities, and collaborates with cross-functional teams to ensure timely market access and product lifecycle management.
Responsibilities
- Coordinate and prepare regulatory document packages for submissions, audits, and inspections
- Compile materials for global submissions, license renewals, amendments, and health authority responses
- Assess regulatory requirements and recommend submission strategies aligned with business needs and timelines
- Review regulatory, technical, quality, and labeling documentation for accuracy and consistency
- Identify regulatory risks and gaps early, escalating issues to support timely resolution
Requirements
- Bachelor's degree required
- Minimum 2 years of relevant regulatory experience
- Knowledge of U.S. FDA and international regulatory requirements for medical devices
- Familiarity with EU MDR, MDD, ISO 13485, and ISO 14971 standards
- Strong written and verbal communication skills
- Ability to manage multiple priorities and deadlines simultaneously
- RAC certification or progress toward certification preferred
Vacancy posted 6 days ago
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