Regulatory Affairs Officer - new job in Edinburgh, UK

Title: Regulatory Affairs Officer - Product Registration & post market compliance

Location: Edinburgh area - hybrid working

Type: Full-time, Permanent

SRG is working with a leading Biotechnology company based in the Edinburgh area who are looking for a Regulatory affairs officer to join their team on a permanent basis.

The Product Registration & Post Market Compliance Officer is responsible for the regulatory registrations to allow for the commercial expansion of our clients product lines by collecting the territory requirements and coordinating the compilation of the registration dossiers for the individual commercial territories.

Additionally, as part of the routine regulatory oversight, the role will be involved in necessary product modifications and in the collection and review of information associated with the products placed on the market, including assisting in the creation and management of the required yearly regulatory summary reports (SSP, PSUR, etc.) to maintain continued IVDR compliance.

Requirements:

• Scientific or Medical degree
• Experience with Product Life-cycle management and global registration activities
• Experience working with in-vitro diagnostics, blood grouping, virology products or med devices.
• Knowledge & practical experience of CE and FDA regulations, including the preparation of PMA, BLA, CE mark and/or 510k submissions
• Excellent relationship building, negotiating and influencing skills

Benefits:

• Private Medical Insurance
• Life insurance
• Income protection

If you would like to apply for this position, please use the link provided. Alternatively please email a copy of your CV For more information regarding this position or any others, please call Aoife on 0141 225 5456.

If you have a scientific background and this position is not relevant / suitable for you, please feel free to get in touch or visit www.srgtalent.com to view our other vacancies .

SRG is the UK's number one recruitment company specialising in the scientific, engineering, clinical, pharmaceutical, food/FMCG, energy & renewables, biotech, chemical and medical device sectors. As scientists ourselves, our specialist sector knowledge and our passion are second to none. It's this combination that makes us different. We're committed to providing outstanding temporary, contract and permanent career opportunities of all levels for our candidates and a comprehensive range of expert strategic recruitment services for our clients

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.