Regulatory Affairs Manager - IVD / ISO13485
Are you an experienced Medical Devices or In-vitro Diagnostics Regulatory Affairs Manager looking for a new exciting job opportunity?
We are currently looking for a Regulatory Affairs Manager to join a growing biotechnology company based in the Manchester area with flexibility of working from home too.
As the Regulatory Affairs Manager you will be responsible for the 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 as well as regulatory authorities.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Regulatory Affairs Manager will be varied however the key duties and responsibilities are as follows:
1. You will be responsible for leading and supporting the preparation of regulatory dossiers to support product license applications, import license applications and maintenance of the same for worldwide Regulatory Authorities as well as lead the creation, management and maintenance of Technical Files / Medical Device Files for the company's product range in accordance with the requirements of the IVDD 98/79/EC and MDD Directive 93/42/EC, including CE-marking activities.
2. You will be managing a small RA team covering all areas of regulatory support for the business, managing relationships with regulatory agencies and authorised representatives as well as being responsible for generating the development of the company's regulatory plan, incorporating strategies for the product range in accordance with global requirements.
3. Additionally, you will 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.
4. As the Regulatory Affairs Manager, you will also develop and coordinate transitional plans, as required, to ensure the business continues to operate to current and future regulatory requirements.
To be successful in your application to this exciting opportunity as the Regulatory Affairs Manager we are looking to identify the following on your profile and past history:
1. Degree educated - preferably in genetics or molecular biology, but other Life Sciences degrees will be considered if you have relevant experience in a similar role.
2. Proven industry experience of working within the MDD/MDR and/or IVD/IVDD/IVDR regulatory affairs area, experience managing an RA team and knowledge of ISO 13485 and IVD/IVDR Directive requirements are essential for this position.
3. A working knowledge/application/training of the IVD/IVDR Regulations and knowledge of EU harmonised standards associated with IVDs are also essential for the position of Regulatory Affairs Manager.
Key Words: Regulatory Affairs Manager | Medical Devices | In-Vitro Diagnostics | IVD | ISO13485 | Life Science | Biotechnology | Healthcare | Quality Assurance
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.