Regulatory Affairs 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