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Quality and Regulatory Manager – Windsor

Full Time Permanent @Medical Device Client in Medical Devices
  • Windsor View on Map
  • Post Date : January 17, 2023
  • Apply Before : March 31, 2023
  • Salary: £70,000.00 - £80,000.00 / Yearly
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  • View(s) 44
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Job Detail

  • Job ID 552
  • Experience 5 Years
  • Industry Medical Device

Job Description

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.

Required skills

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