Regulatory Affairs Executive

5 days ago

Hemel Hempstead Industrial Estate, United Kingdom Kenton Black Science & Engineering Full time

Regulatory Affairs Executive
Do you want to contribute to the future of healthcare? Do you want to work for a progressive company that offers long term training and development?
I working in partnership with a leading healthcare manufacturer, they specialise in the development of new products, using their unique technology platform. Due to growth in the business, they are looking for a Regulatory Affairs Executive / Specialist to jointhe Regulatory Affairs Team.
The Regulatory Team is dynamic and successful there unique team spirit arises from embracing different perspectives, open debate, and the will to challenge conventions. Change is a constant aspect of there work, but they work together to reach the goals neededfor the business.
The Role:

- You will be involved in supporting registrations and licences in line with relevant regulatory frameworks to enable product sales.
- This includes organising any necessary testing; submission of dossiers and ensuring suitability of product labelling.
- Maintain an awareness and ensure compliance with relevant regulations and laws in all markets.
- Monitor and communicate changes to applicable regulatory requirements.
- Maintaining an awareness of regulatory requirements, advising the business on regulatory topics and supporting NPD projects teams to obtain relevant registrations, clearances and licences.
- Good background in Regulatory Affairs, ideally with experience within the Medical Devices.
- Experience in a role working with Medical Devices is required, preferably Class I-III Devices.
- Detailed knowledge of regulatory requirements in Europe, USA & APAC are highly desirable.
- Self-motivated with the ability to deliver a high standard of work within agreed deadlines.
- Excellent interpersonal and organisational skills. Must be able to work well within a team and display strong problem solving skills.
- Must work efficiently and be self-disciplined. Able to work well under pressure and to be able to identify the need to prioritise when required.

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