Regulatory Affair Specialist

2 weeks ago

South West London, United Kingdom Harrington Recruitment Ltd Full time

**The Role**

The Regulatory Affairs Specialist will report to the Commercial Director. This is expected to be a hybrid role, 3 days per week working from home and 2 days based South-West London. The person should be located a commutable distance to the office.. Working together with colleagues in Germany, the Regulatory Affairs Specialist will be required to ensure that all UK specific requirements are met, including the necessary paperwork, and all saleable products are registered prior to order processing by the Orders and Logistics department. The successful person will be enthusiastic about Regulatory & Clinical Affairs, QM, and have the ability to process legislative documentation such as standards in order to evaluate the impact on the business and be able to liaise these to senior managers. This will require close working networks with members of all departments to enable the company to deliver the best customer service solutions possible.

**Duties & Responsibilities**
- Support the UK RA department as well as our Central Regulatory Affairs team
- Support the planning and execution of regulatory duties for the registration of the assigned product portfolio
- Push results through being a well-organized team player with a focused and disciplined approach to achieve the joint goals
- Collaborate with our headquarters in Germany and our national subsidiary
- Support all pre-market and post-market regulatory activities of the assigned product portfolio
- Keep track of the national and international requirements for product registrations
- Work with the product teams to ensure the products and similar documentation are compliant with the regulatory requirements
- Support the national and international Regulatory Affairs teams with national MHRA registrations and the regulatory transformation for compliance to the new EU IVD Regulation 2017/746
- Create registration dossiers used for registration at international authorities
- Be actively involved and contribute from the regulatory perspective to compliance of the company to any relevant standards including but not limited to ISO27001 and ISO9001

**Qualifications**
- Bachelors (or similar), medical technology or related sector
- Laboratory Experience
- Fluency in English
- Proven business acumen
- Experience in the in-vitro diagnostics sector

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