Regulatory Affairs Engineer/Specialist

Ref No. 22478
Wales - Monmouthshire
Posted 15 Oct 2020

Overview

Salary: Please contact us

Employment: Permanent

Job description

Regulatory Affairs Engineer/Specialist

 

This highly innovative medical device manufacturer is actively looking for a Regulatory Affairs Engineer/Specialist to join their team. They are genuinely revolutionising certain applications withing their field and the successful candidate will be working on high tech, innovative products which will have a huge impact on people’s lives.

 

As a Regulatory Affairs Engineer/Specialist, you will be working with multiple product development teams supporting regulatory approvals as well as maintaining clinical literature and clinical evaluation reports. You will also be responsible for planning, managing and support of clinical trials.

 

On offer is a highly competitive salary and benefits package as well as the opportunity to work on genuinely innovative products within a rapidly growing company.

 

Responsibilities:

 

To collaborate, author and/or review clinical evaluation reports for new product development

Undertake and/or oversee literature searches

Identify complications and side-effects for the intended use of devices

Support, review and revision of clinical evaluations per MDD/MDR

Work with Development teams in the preparation of regulatory documents

Support CE marking and FDA submission processes

Performing tasks relating to regulatory affairs

Manage and conduct a programme of studies and related clinical activities

Support project teams and provide regulatory and commercial support

Drafting and approval of study protocols

Primary contact and coordination of development teams, study sponsors, clinical test facilities, clinicians and CROs.

Identify complications and side-effects, including incident rates, for the intended use of devices

Support to the establishment, review and revision of the clinical evaluation per MDD/MDR.

Provide support during ISO 13485 and other QMS/regulatory compliance audits and inspections

 

Qualifications/Experience:

 

Experience within the medical device industry

Extensive regulatory affairs experience

Experience with MMD, MDR, FDA 510K, CE marking, ISO 14917, ISO 13485 etc.

Ideally degree educated within a science or engineering discipline

 

Your consultant

Richard Andrews

Engineering Team Lead

Get in touch:

r.andrews@intapeople.com