Regulatory Affairs Manager: European Union expertise-Medical Device

Onsite Role (relo available) Will consider those hybrid and remote candidates.

Our client 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.

KEYWORDS

#regulatoryaffairs #eumdm #medicaldevice #regulatory #fda #compliance