Regulatory Affairs Manager Med Device EU expertise

Regulatory Affairs Manager (European Union expertise)

Medical Device Company. Tucson AZ

Onsite (relo over time) 140k

Talentry is looking for a Regulatory Affairs expert with medical device experience in the European Union (EM MDR). This expert will aid in the preparation of documentation submissions applications responses adverse reports deficiency letter responses etc. supporting the EU and other international regulatory paradigms.

The best person for this role will prepare documentation monitor and track control systems research regulatory issues and trends etc. He or she will also respond to NCRs and Quality System deficiencies.

Requirements

BS or similar and 6 years of experience.

Proven experience with EU MDR experience.

Excellent communication and documentation experience.

Detail oriented proactive.