Regulatory Affairs Manager

  • Category
    Scientific - Regulatory Affairs
  • Location
    Manchester, Manchester
  • External Reference
    JN-062021-187740
  • OrganizationType
    IT

Regulatory Affairs Manager

Manchester


Spring are recruiting for a Regulatory Affairs Manager to join a highly successful and rapidly growing organistation. The Regulatory Affairs Manager will need to have expert knowledge within the in-vitro diagnostics (IVD) industry and experience of managing RA teams.

The role of Regulatory Affairs Manager will will help support effective management of the organisation's regulatory affairs strategy, in order to support and fulfil the company's global commercial strategy. The role requires management and liaison with the senior management team, internal team functions, regulatory authorities and partner organisation's.


Responsibilities

- Managing a small RA team covering all areas of regulatory support for the business
- Lead the creation, management and maintenance of Technical Files / Medical Device Files for the product range in accordance with the requirements of the IVDD 98/79/EC and MDD Directive 93/42/EC, including CE-marking activities
- Manage and lead the IVD/IVDR planning transition for the business
- Experience of country approval (e.g. FDA, TGA, HC and ANVISA) and registration processes for worldwide commercial support
- Lead and support the 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
- Maintain a high level of specialist knowledge of the regulatory requirements within each of operational geographical territories
- Manage the collation, interpretation and dissemination of specialised regulatory information across the business
- Generate the development of the company's regulatory plan, incorporating strategies for the product range in accordance with global requirements
- Actively monitor the regulatory environment, assessing the impact of new or changing regulations to the business
- Develop and coordinate transitional plans, as required, 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 life-cycle of marketed products
- Provide regulatory direction and 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 organisation's 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
- Support third party assessments


If you are an experienced Regulatory Affairs Manager with a strong background in IVD and exposure to global markets, please APPLY NOW!

Regulatory Affairs Manager, IVD, Manchester


Spring acts as an employment agency for permanent recruitment and an employment business for the supply of temporary workers. The Spring Group UK is an Equal Opportunities Employer.

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To speak to a recruitment expert please contact Iain Mcculley