Regulatory Affairs Officer, Medical Devices
Location: Home-based with occasional site visits.
Salary: Competitive DOE
Additional: Company laptop provided, company pension
Our Client a rapidly growing medical devices company, is looking to appoint an experienced Regulatory professional who will play a key part in the companies expansion plans and development/ preservation of the QMS and related RA activites.
- Support audit preparation activities
- Compile, submit and monitor regulatory submissions to gain approval to market products
- Assist in performing gap analysis
- Involvement in regulatory team meetings and manage assigned tasks with regular updates to the team
- Ensuring that submissions and QMS are inline with ISO13485 accreditation
- Ensure that planning, preparing, tracking, and storing submissions to regulatory agencies are regularly updated and used.
- Communicate efficiently with key stakeholders both internally and externally- building a good relationship with them!
- Ensure familiarity with the company's product range and keep up to date with the company's regulatory standards and legislation for both UK and EU. As well as ensuring quality standards are consistently met and submissions are made accordingly.
- For both national and mutual recognition procedures prepare, compile, and submit a range of regulatory applications
- Review and update SOPS to ensure they comply with applicable legislation with the UK & EU
- Will hold a Degree in a relevant, Scientific discipline
- A minimum of 2 years RA experience within the medical devices industry
- MUST HAVE- ISO 13485 RA experience (dealing with medical devices submissions)
- Experience of writing and updating product information documents to an excellent standard..