Regulatory Affairs Associate

Oxford Gene Technology (OGT) provides world-class genetics research solutions to leading clinical and academic research institutions.  A rapidly growing company with state-of-the-art facilities and over 100 employees based at our head-office in Begbroke, Oxfordshire, or at our Cytocell ® office in Cambridge, Cambridgeshire.  With customers in over 60 countries worldwide and ambitious expansion plans, OGT has a strong reputation and increasing share in the large and growing genomic medicine market. 

Due to continued growth we have a fantastic opportunity for someone to join us as a Regulatory Affairs (RA) Associate, based at our Cambridge site. This is a busy role, providing RA support to enable the company to meet the business system and regulatory compliance requirements of the markets in which its products are developed, performance evaluated, clinically validated, manufactured and/or distributed.

Reporting to a Regulatory Affairs Specialist, this role will have a variety of duties within the RA team which include:

·         Maintain a good knowledge of specific country/regional regulatory frameworks

·         Supporting the Quality Assurance department with respect to ISO13485 audits.

·         Creation and update of regulatory documents such as STED’s.

·         Handling registration activities for defined geographical regions.

·         Ensure IFUs are kept up to date and reflect the state of the product

·         Coordinate the translation process with external agencies

·         Maintain knowledge of the company’s portfolio with respect to the technical and scientific environment, clinical purpose and regulatory framework.

·         To update on the progress of registration processes and other RA group activities to line management when requested.

·         Review and approve labelling to ensure regulatory compliance.

·         Liaise with distributors, 3rd parties and international regulatory agencies and provide supporting documentation, handling queries, issues and complaints.

·         As required, support post market surveillance activities.

·         Carrying out periodical reviews of worldwide regulatory framework for existing and new markets. Liaising with key stakeholders to maintain Quality

·         Management System processes and submission documentation for the continuing compliance of the company’s portfolio.

·         To complete any other tasks as commensurate with the level and nature of the post as delegated by the Director of Medical & Regulatory Affairs.

To be successful in this role you will need:

·         Degree-level education

·         Some experience of working in a regulated IVD environment.

·         Some experience of working to ISO 13485 as well as 21CFR 820 Quality System Regulation

·         Knowledge of working with documentation for global regulatory submissions/registrations

·         Knowledge of medical device adverse event and recall reporting regulations

This is a great opportunity for someone who wants to develop their career in IVD regulatory affairs.  It will suit someone who is self-motivated, takes the initiative to work through problems, and demonstrates flexibility and resilience in order to meet the demands of the role.

In return we offer:

• Competitive salary
• Pension - 10% non-contributory
• Private Healthcare with BUPA
• 21 days holiday + UK public holidays increasing with service

If you believe this is the role for you then please provide a CV, along with a covering letter outlining your suitability for the role, salary expectations, and confirming you have the right to work in the UK to vacancies@ogt.com by 13th March 2020.

All candidates will be required to confirm eligibility to work in the UK before starting employment.

No agencies please