Principal Regulatory Affairs Specialist - Oxford, United Kingdom - Cpl Life Sciences

Cpl Life Sciences

Verified Company

Oxford, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Reference Number:

JO
Principal Regulatory Affairs Specialist

Rate:
£60, ,000

Job Type:
Permanent

Location:
Oxford

Job Title:
Principal Regulatory Affairs Specialist

Job Type:
Permanent

Location:
Oxford
shire based

Salary:
£60,000 - £75,000 plus attractive benefits

This is fantastic opportunity to work with a leading Global Healthcare Provider for Medical Devices and Diagnostics who are now recruiting for a Principal Regulatory Affairs Specialist.

Supporting a rapidly expanding team and business, this organisation has recently won multiple innovation awards for its vast product portfolio.

As a Principal Regulatory Affairs specialist you will be responsible for leading new registrations in the UK, EU, Middle East, and Pakistan including driving all regulatory strategies and working closely with the wider RA team.

This is an excellent opportunity to join a leading organsiation that is rapidly growing and is working at the heart of innovation.

This opportunity comes with exciting career development opportunities including offering an attractive package and a range of benefits.

Role Responsibilities include;

Execute and ensure Product Registration, release Authorization and release for Distribution.
Oversee processes and team involved with obtaining and maintaining product registration, release authorization, and release of product to specified geographies.
Develop processes and tools to support controlled product release.
Product Registration, Release Authorization and Release Planning
Provide Regulatory input to strategy based upon regulatory changes
Coordinate with crossfunctional teams including but not limited to: US Regulatory, International Regulatory, Marketing / PLC, Supply Planning, Customer Service, Quality, R&D, Operations, etc. to ensure all internal and external requirements are met prior to product release. Identify risk areas and escalate issues as appropriate. Manage multiple programs with mínimal oversight.
Eligibility to live and work in the United Kingdom
Life Science degree or equivalent, preferably in a Scientific discipline
Experienced in regulatory submissions for in vitro diagnostic devices and/or medical devices.
Experience working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).