6 months ago
Hamlyn Williams has partnered with a leading Medical technology company that is looking for a Clinical and Regulatory manager to join their team.
The role will involve:
- Ensuring that regulatory requirements are translated into technical requirements for product
- Ensure appropriate Post Market Surveillance of the products and take necessary actions.
- Coordination and implementation of internal audits
- Act as person responsible for regulatory compliance (PRRC) under the MDR.
- Plan & Manage the clinical evaluation of SaMD.
As a Regulatory manager you will need:
- Medical device background
- Documented knowledge/experience within medical quality and regulatory assurance.
- Prior experience in managing Clinical Evaluations & Investigations
- Good working knowledge of the CE marking process & 510K clearance
- IS013485 and IS014971 experience
I am a Quality Assurance and Regulatory Affairs market specialist working with a large variety of clients across the Medical Device industries. If this role is of interest to you, or if you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Leah at +44 020 3545 1118 or at firstname.lastname@example.org.