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Job Description
Support the Peripheral Vascular Health business as an Associate Regulatory Affairs Specialist, maintaining regulatory approvals and assessing device changes for registration implications.
Key responsibilities include:
- Contribute to global product registration maintenance, including EU MDR Technical Documentation/MDD Technical Files and Global Submission Summary Document.
- Participate in preparation for and during internal and external regulatory audits.
- Compile materials required for new global product submissions, license renewals, change submissions, and tenders.
- Monitor and improve global regulatory tracking/control systems.
- Request, obtain, and maintain FDA CFGs, including notarization and legalization, EC/ISO certificates, and various other regulatory documents.
- Participate in investigative activities, such as CAPA's and non-conforming product.
Requirements:
- Bachelor's Degree in a health profession, science, and/or engineering field.
- Demonstrated technical writing skills.
- Strong computer skills, including word processing, spreadsheets, and slide presentations.
- Excellent organizational skills.
- Strong written, verbal, and interpersonal skills.
Medtronic offers a competitive salary and flexible benefits package, as well as a commitment to employee well-being and success.
Medtronic is a global leader in healthcare technology, dedicated to alleviating pain, restoring health, and extending life.