The role: To provide regulatory expertise in the research, development and marketing of Advanced Wound Management products and to ensure that regulatory approvals are obtained...
- Offer general advice on regulatory strategy for new products and product changes.
- Working on 510k submission on a day to day basis with minimal supervision.
- Provide updates on the progress of registration processes and other RA group activities to line management when requested.
- Assistance with the regulatory compliance of marketing communications/messages.
- Contribute to the development and implementation of regulatory policies, procedures and specifications across the company and ensuring that these are compliant with the Quality System.
- Undertake CE marking activities and has a good understanding of the requirements of the IVD directive. Ability to recognize post market surveillance issues that require corrective action and reporting.
Life sciences qualified.
- A scientific, medical or engineering background.
- Significant regulatory experience.
- Knowledge of the IVD industry or the medical devices industry.
- Knowledge of GMPs/ISO13485, FDA 21 CFR 820 - 510k process, IVDD - CE marking and ROW regulations/registration processes.
- Understanding of pre/post marketing regulatory affairs.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.