Job Ref: 212673018

Date: 2020-10-30 11:12:50

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Title: Regulatory Affairs Supervisor/ Manager

Location: Bucks (commutable from London via M40)

My client is a reputable Medical Device Company; based in Buckinghamshire; and they have an exciting new opportunity to strengthen their team with a Regulatory Affairs Supervisor/ Manager.

Technical Specification

* 5 years’ experience with MDD technical file writing and approval (Class 1, Class IIa, Class IIb)

Plus experience of as many of these additional items:

* Implementation of PMCF plans

* PMS data collection, analysis, reporting

* Clinical Evaluation Report writing, review and update

* Foreign market requirements: USA, Canada, Australia, Brazil, EU

* Supporting regulatory aspects of MDSAP audits

* Supporting Notified Body technical file assessments

* MDR planning and implementation

* Foreign market registrations worldwide (excluding; China, Russia, Japan, )

* Regulatory input and activities for the design and development process

* Working with or working as an Authorised Representative for MDD/MDR

Person Specification

* Leadership of the Regulatory Team including developing junior team members

* Supportive

* Eager to share knowledge

* Open with plans and tasks

* Good delegation

* Ownership of Regulatory outputs for the company

* Planning; short and long term

* Prioritisation of tasks and resource

* Attention to detail

A competitive salary is on offer plus 1 day working from home per week and more benefits

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