As Regulatory Affairs Manager you will be responsible for ensuring continued compliance to all relevant regulatory and quality requirements. Timely identification to regulatory changes will be essential to ensure that there are no negative impacts on the business as will making sure that all current regulations and standards are available across departments. You will be responsible for the generation and maintenance of the DMR, Recall files, risk management files & other technical documents relating to compliance. Another key aspect is the responsibility to support and supply information as required relating to product registration in any market including site registrations including FDA 510(k), CE Marking etc. Support of change management processes is also important and you will need to report changes as appropriate. You will also have to contribute to the maintenance of SOPs.
Key Qualifications/Experience required includes:
- University degree in a scientific/engineering subject
- Past experience in a regulatory or quality role at a Medical Device manufacturer
- A good knowledge of ISO 9001, ISO 13485 & FDA regulations
To apply please send your CV to firstname.lastname@example.org and successful applicants will be contacted within 7 days.