Due to continued investment, a medical device start-up has an exciting opportunity for a Regulatory Affairs Manager to join its team. As Regulatory Affairs Manager, you will manage drafting the company's regulatory documentation, as well as managing our Technical Files and Contractors. You must have proven experience of working to EU Medical Device Regulations and ISO 13485 standards.
As Regulatory Affairs Manager, you will manage drafting the company's regulatory documentation, as well as managing our Technical Files and Contractors. You will work directly with the technical team and highly experienced Contractors to help bring each product through the medical device regulatory pathway.
This is an exciting opportunity to join an award-winning, ambitious start-up in which you can have a real impact during an exciting stage of development.
- BSc/MSc in Life Sciences or relevant degree
- Excellent knowledge of EU Medical Device Regulations
- Understanding of EU regulatory pathway for Class II and Class III medical devices, including required tests and data to secure a CE mark.
- Good knowledge of relevant ISO standards (e.g. 13485, 10993, 14971…).
- Experience writing regulatory documentation, including risk assessments, technical files and design history files.
- Ability to work independently to manage and prioritise workload, and also work collaboratively as part of a team.
- Assistance in compiling documentation for clinical trials
- Correspondence with MHRA
- Writing strong rationale documents
- Knowledge of devices/therapies using antibodies
- Biological and toxicological evaluations
- Competitive salary
- Remote work
- 3% Company pension
- 25 days holiday
- Share options scheme
- Free beer Thursdays and Fridays in the office
You must be eligible to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Reference: 6691
- Updated: 23rd November 2020
- Expires: 21st December 2020