Principal Regulatory Affairs Specialist - Witney, United Kingdom - Hobson Prior

Hobson Prior
Hobson Prior
Verified Company
Witney, United Kingdom

3 weeks ago

Tom O´Connor

Posted by:

Tom O´Connor

beBee Recruiter
Description

Salary:

£ £75000 per annum
Job type:

Permanent


Location:

Witney, England


Function:

Regulatory Affairs, Operations


Posted:15/08/2023


Ref:

BBBH2338- Hi I'm
Catherine
, I manage this role


Hobson Prior are currently seeking for a Principal Regulatory Affairs Specialist to join a fantastic medical devices organisation on a permanent basis.

Our client is focused on developing and manufacturing systems for both home and hospital use.

Please note that to be considered for this role you must have the right to work in this location.


Key Responsibilities:


  • For this position, you will hire and retain a diverse, highly qualified personnel and offer ongoing performance feedback.
  • Uphold a safe and professional work setting.
  • As the Principal Regulatory Affairs Specialist, you will uphold positive and collaborative discussions and cooperation with all levels of staff, customers, contractors and vendors.
  • Responsible for product release process ownership.
  • Serve as a mediator with all other divisions such as Quality, R&D, Legal, Operations, Marketing and Clinical Affairs, for major initiatives.
  • Product registration, release authorisation and release for distribution as well as release planning.
  • You will conform to US DA and global guidelines, and any other regulatory needs, company policies, operating processes, procedures and task assignments.
  • Accountable for analysing productconnected issues and develop submissions for resolution.
  • Any other assigned duties.

Requirements:


  • Educated to a degree level or corresponding ideally in a scientific field such as life science, biology, chemistry, etc.
  • At least 7 years of experience working with regulatory proposals for in vitro diagnostic devices and/or medical devices for the US and EU.
  • Previous involvement working within the necessities of ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
  • Ideally attained software familiarity.


Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.

Hobson Prior is acting as an Employment Agency in relation to this vacancy.
More jobs from Hobson Prior
See all jobs of Hobson Prior