Regulatory Affairs Specialist

Hobson Prior currently have an exciting new opportunity for a Regulatory Affairs Specialist to join one of the world's leading specialised medical diagnostic companies on a permanent basis in Birmingham.

Job Responsibilities:

• Accountable for regulatory review and inputs for controlled documents.
• You will assist in compilation of global regulatory affairs submissions including STED CE file, FDA.
• You will assist in all regulatory affairs activities contributing to overall company objectives.
• Support internal audits and 3rd party audits.
• Support compliance activities for QMS to meet regulatory requirements including MDSAP.
• Multi-department and multi-level interactions.

Key Skills:

• Ability to work with teams and gain consensus.
• Ability to assess options to support decision making process.

Requirements:

• Sc. in Life sciences.
• A minimum of 2- 5 years in QA/RA roles in healthcare industry (pharma, medical devices or diagnostics).
• A minimum of 2- 5 years working in cGMP or regulated environment compliant with ISO13485, 21 CFR part 820 or equivalent.
• Experience of working teams in a regulated industry.
• Scientific knowledge and experience or working with healthcare products.
• Regulatory Affairs and / or Quality assurance background.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.