Regulatory Affairs Associate

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

An opportunity has arisen to join our Cambridge-based Regulatory, Medical and Quality Affairs Department, which is responsible for ensuring that OGT’s products are safe, effective and compliant to global medical device regulations.

Reporting to Regulatory Affairs Specialist, you will provide Regulatory Affairs 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.

Your duties will include:

• Maintaining a good knowledge of specific country/regional regulatory frameworks
• Supporting the Quality Assurance department with respect to ISO13485 audits
• Creating and updating regulatory documents such as STED’s
• Handling registration activities for defined geographical regions
• Ensuring IFUs are kept up to date and reflect the state of the product
• Coordinating the translation process with external agencies
• Maintaining knowledge of the company’s portfolio with respect to the technical and scientific environment, clinical purpose and regulatory framework
• Providing progress updates of registration processes and other RA group activities to line management when requested
• Reviewing and approving labelling to ensure regulatory compliance
• Liaising with distributors, 3rd parties and international regulatory agencies and provide supporting documentation, handling queries, issues and complaints.
• Carrying out periodical reviews of worldwide regulatory framework for existing and new markets, this includes liaising with key stakeholders to maintain quality

You will have:

• A good first degree, A-Levels or equivalent qualification in a biological or scientific related discipline
• Demonstrable experience within a regulated IVD environment (desirable)
• Demonstrable experience working to ISO 13485 along with 21CFR 820 Quality System Regulation (desirable)
• Knowledge of medical device advert event and recall reporting regulations (desirable)
• Knowledge of working with documentation for global regulatory submissions/registrations (desirable)
• A desire to develop a career in Medical Device/IVD regulatory affairs
• An organised approach to work
• A good eye for detail

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 you will receive:

• Competitive salary
• Pension Scheme (10% non-contributory)
• Private Health Insurance
• 21 days holiday rising with service
• High Street Discount Scheme

Application is via CV & a one-page 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

Closing date for applications is 8 January 2021.

No agencies please