Job ID 552
Experience 5 Years
Industry Medical Device
The Quality and Regulatory Manager will play a key role in ensuring that the company’s medical devices comply with current and future regulations. The individual in this role will be responsible for:
- Drafting registration submissions for medical devices and providing guidance on compliance with current and upcoming regulations.
- Developing, implementing, and maintaining processes and procedures that align with the company’s growth strategy.
- Conducting quality system evaluations and/or audits to ensure compliance with ISO 13485 and MDR.
- Preparing and maintaining all necessary technical documentation, submitting them for review and approval by regulatory bodies as required
- Communicating and coordinating with the company’s legal representatives outside of the UK.
- Offering guidance, input, and direction for regulatory and quality aspects of new product development programs to support the company’s growth plans.
The ideal candidate for this role will have a thorough understanding of medical device regulations, experience with implementing and maintaining Quality Management Systems (QMS), and a history of successfully preparing registration submissions for medical devices. Strong leadership and communication skills are also vital for this role.