Specialists in Pharma, Clinical & IT Recruitment

Regulatory Affairs Manager

Job Type(s):
Regulatory Affairs
Salary negotiable
Excellent Benefits
Contract Type:
Date Posted:
17/01/2014 16:45:00
Start Date:
End Date:


My client an International Medical Device company has opened a new vacancy within their Regulatory Affairs team. They are actively looking to hire a Regulatory Affairs Manager to join their team on their offices on a permanent basis in Manchester.

Key Responsibilities:

·         Ensuring compliance with global regulatory requirements

·         Taking overall responsibility as ‘Regulatory Lead’ for Companion Diagnostic development projects

·         Participation in project teams to provide regulatory input into cross departmental

International registration projects

·         Preparation of documentation in order to support Global regulatory

·         submissions

·         Review and approval of labelling, advertising and promotional materials in

·         order to ensure regulatory compliance

·         Supporting Post-Market Surveillance and Vigilance activities



Position requirements, qualifications and experiences:

·         Minimum scientific degree (or equivalent) in life sciences

·         Extensive experience in a similar role within the medical device industry,

(Preferably in vitro diagnostics). Working knowledge of the MDD and

IVDD, applicable ISO standards and US medical device/IVD regulation

·         Good interpersonal and communication skills

·         Ability to handle multiple projects simultaneously

·         Ability to work with minimal supervision


For more information regarding this vacancy or a confidential job discussion, please get in touch with Neal Panting. Neal@arc-7.com or +441483 397070