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Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs Specialist
Contract Type: Permanent
Location: Cheshire, England
Salary: Negotiable
Reference: BBBH10453_1537960707
Contact Name: Jacob Golding
Contact Email: jacob@emp-sol.com
Job Published: September 26, 2018 12:18

Job Description


We have an exciting new opportunity to join a large, global and growing Medical Devices company as a Senior Regulatory Affairs Specialist to become an integral part of the company.

This is home based position (anywhere in Europe) with around 20% travel involved.

You will be responsible for creating, compiling and maintaining Regulatory Files including Design Dossiers, 510(k) submissions, PMA submissions and Technical files.

You will submit regulatory affairs approvals to EU & US regulatory authorities on behalf of the company to meet business requirements.

You will predominantly work with Class III / Class 3 Medical Devices.

You will provide regulatory input to new product developments (NPD).

Skills and Experience:

Minimum of 5 years in Regulatory Affairs.

Proven experience in submitting EU & US submissions.

Excellent knowledge of Class III Medical Devices.

Position requires a minimum of 20% travel.

Salary Competitive (Senior salary - dependent on experience)
Permanent contract Full Time + Benefits
Location: Home Based (Anywhere in Europe) + Travel

Contact Jacob Golding for further details on 0161 839 5353 - jacob@emp-sol.com