Regulatory Affairs Manager / RA / CE Marking / Technical Files / Submi

Recruiter
X4 Group Ltd
Location
London, Greater London
Salary
£45000 - £55000/annum
Posted
09 Jul 2017
Closes
08 Aug 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Regulatory Affairs Specialist / RA / ISO 13485 / Medical Devices

Salary: £50,000 - £55,000

Location: London

Regulatory Affairs Specialist / RA / ISO 13485 / Medical Devices specialist needed to join a growing medical device manufacturer.

Regulatory Affairs Specialist / RA / ISO 13485 / Medical Devices – Key responsibilities:

* CE Marking Submission applications for US and Asian markets
* Support and provide guidance for EMEA registration
* Prepare all future 510(k) submissions for FDA approval
* Ensure all dossiers are technically accurate
* Provide regulatory support to supply and marketing in accordance to specific market regulations
* Provide training and liaise with all relevant departments to ensure complete compliance to all regulatory standards.

Regulatory Affairs Specialist / RA / ISO 13485 / Medical Devices – Key Experiences

* Must have proven working knowledge as a Regulatory Professional for a minimum of 10 years
* Must have at least 10 years’ experience within an ISO 13485 environment
* Experience of FDA, MHRA, MDD is also highly advantageous
* Degree level or equivalent experience with either a Scientific, Management, Quality or Engineering background is highly desirable
* Multiple highly regulated industry background (E.g. Food, Cosmetics, Pharmaceuticals) as well as Medical Devices.

The ideal individual for the position will either have a strong academic background who is looking for a role in which the full Regulatory Affairs spectrum is covered or an experienced professional who is looking for the exciting challenge of assisting with the fast expansion of the company. The RA Manager will need to be hands on and have some form of business facing experience.

If you would like to apply for this role please apply online and call Jack on (Apply online only).

Key Skills: Regulatory Affairs Manager / RA / CE Marking / Technical Files / Submissions / Pre-market Approvals / FDA / MHRA / MDD / 510(k)