Regulatory Affairs Manager – Full Time – Northwich

Regulatory Affairs Manager– £50,000 – £60,000 pa + benefits – Ref 213

Remote working available

I am currently recruiting for a Regulatory Affairs Associate to work for a multi-national medical device organisation. Salary up to £60,000 + benefits.

Duties:

• Manage development and implementation of regulatory strategies for RA staff for Class I, II, and III devices

• Provide leadership, personnel development, coaching, and mentoring to staff

• Provides regulatory guidance to site

• Ensures adherence to company procedures for the timely approval of new products. Oversees the preparation and maintenance of regulatory submissions including US 510(k), IDE, and PMA files and EU Technical Documentation

• Manages internal and external audits

• Promote health and safety policies

Skills needed:

• Strong Regulatory Affairs experience

• People management experience of at least 2 direct reports is desirable

• In-depth understanding of global medical device regulations and demonstrated experience with US Class II, III

• Experience Medical Device Reporting

• Ability to work independently on own initiative with minimal supervision

This is an immediate requirement so if you have the required skills and experience then please get in touch ASAP with an up to date copy of your CV. Either apply direct or contact David on (phone number removed).

Salary: £50000 – £60000/annum

Job Type: Permanent

Location: Northwich, Cheshire West and Chester