Our client, a world-leading manufacturer of diagnostic reagents are looking for a Senior Regulatory Affairs officer to join their team in Scotland.
As Senior Regulatory Affairs Officer, you will be responsible for managing, preparing and maintaining regulatory documentation to enable the company to comply with ISO9001 and ISO13485 standards and to ensure on-going regulatory compliance to GMP. You will also be responsible for gaining CE marking for new products in the EU, registration via competent authorities and FDA approval for products in the US, while maintaining existing licences and registrations.
Further responsibilities include:
- Plan, co-ordinate, prepare and interpret relevant information necessary for product licence applications to ensure successful granting, maintenance and development of such licenses by Regulatory Authorities on a world wide basis.
- Advise staff on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
- Compile product information for the preparation of technical files and regulatory dossiers to support product licence applications and product license maintenance for world wide Regulatory Authorities.
- Ensure that changes are communicated as appropriate to the Regulatory Authorities
- Liaise with regulatory agencies and external contract bodies and, in response to requests from these, to collate and interpret specialised information
- Provide advice on the licensing options/regulatory requirements for the company, to facilitate process/product modifications
- Contribute to the design and implementation of new systems and procedures and identify areas for potential improvement to ensure the concept of continuous quality improvement is realised
- Participate as required in the selection and recruitment of new staff and participate in induction programmes for new starts in relation to Regulatory Affairs
Qualification and Experience:
The ideal candidate for this Senior Regulatory Affairs Officer position must hold a relevant degree or professional qualification and an appropriate level of experience in a Regulatory Affairs environment, significant specialist knowledge of Regulatory Affairs and an understanding of the operation of a medical device manufacturing establishment (ideally as applied to in vitro diagnostic medical devices). As well as the ability to analyse information in a structured manner and to be able to prepare coherent regulatory reports and filings.
For more information or to apply for this Senior Regulatory Affairs Officer position, please contact Carrie Ann on 0191 384 8905 or firstname.lastname@example.org. Please quote reference DH21857 in all correspondence.