- Excellent Manufacturing business
- Global Responsibilities
Regulatory Affairs Manager
We are currently helping a Leading Medical Device business in their search for a Regulatory Affairs Manager. This is a key role for the business that will shape the Regulatory Team and their strategy for the coming 12 months and will offer the successful candidate an excellent opportunity to develop their career in a world-class Manufacturing facility.
This is a key role for the business as they aim to achieve their ambitious goals for 2020. As a key member of the Regulatory Affairs team, the successful candidate will have significant responsibilities within the UK Manufacturing operation, providing an early warning system for regulatory changes before they happen.
In particular, you will have responsibility for
- Providing guidance on product regulation
- Help the business to access new markets – through regulatory submissions for regulated products
- Provide regulatory affairs support within New Product Development
- Review compliance for promotional labelling
- Continuous improvement of regulatory process
The successful candidate is likely to currently be a Regulatory Affairs Manager within a Medical Device company. We are open on the specific background, however you will have a demonstrable history of working within Quality Assurance and Compliance within Regulated industries – specifically Medical Device or Pharmaceutical Technology.
You will also be able to demonstrate:
- A Master of Science Degree (Mechanical/Industrial/Electrical Engineering) or equivalent Engineering Degree
- An excellent ability to interpret Authority Regulations is essential
- A knowledge and appreciation of compliance work