Regulatory Affairs Manager
SRG partner with a leading Medical Diagnostics company, who boast international success in providing a range of complex diagnostics to both the commercial and personal use diagnostics market.
As Regulatory Affairs Manager, your experience within either the IVD, or Medical Device arena is required to lead a small team based in Manchester. Through a mix of both remote, and office based work, you will work within the senior management team to ensure global commercial strategy is achieved. Responsibilities
Skills and Experience
- Managing a small RA team covering all areas of regulatory support
- Generate the development of the regulatory strategy, incorporating product ranges in accordance with global requirements
- Lead the creation, management and maintenance of Technical Files / Medical Device Files in accordance with the requirements of the IVDD 98/79/EC and MDD Directive 93/42/EC including CE-marking activities
- Manage/Lead the IVDR planning transition for the business
- Preparation of regulatory dossiers to support product license applications, import license applications and maintenance of the same for worldwide Regulatory Authorities
- Proactively manage relationships and communications with regulatory agencies and authorised representatives
- Educate and inform the wider business on their interpretation of specialised regulatory information
- Actively monitor the regulatory environment, assessing the impact of new or changing regulations to the business.
- Develop transitional plans to ensure the business continues to operate to current and future regulatory requirements.
- Provide regulatory direction and support for the product risk management activities and the lifecycle of marketed products.
- Support for post market surveillance, preparing reports for the product range, annually.
- Oversee the issuance of regulatory compliant product labelling and Instructions For Use documentation, liaising with other departments, including the provision of translations from translation service providers
- Lead and participate in medical device reporting, product recall and withdrawals events, liaising with internal management, regulatory authorities, and partner organisations, as appropriate
- Lead the regulatory requirements of the product development process, contributing to product validation plans, reports, claim support papers and other post market activities
- Conduct all duties in compliance with GMP, ISO13485, ISO9001, GCP and other regulatory requirements, as identified.
- Experience of country approval (e.g. FDA, TGA, HC and ANVISA) and registration processes for worldwide commercial support
- Knowledge of ISO 13485 and IVD Directive requirements.
- Knowledge/application/training of the IVD Regulations.
- Knowledge/application of EU harmonised standards associated with IVDs
- Evidenced experience of successfully managing/leading an RA team
- A degree in Life Sciences, either in genetics or molecular biology.
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.