Quality Assurance Regulatory Affairs Manager

3 weeks ago

London, United Kingdom Energy Jobline ZR Full time

Job Description

Quality Assurance, Regulatory Affairs Manager

A hybrid role working across both Quality and Regulatory Affairs, building processes suitable for a fast-growing company, aimed at establishing streamlined processes conducive to rapid expansion, while fostering innovation and research and development initiatives. This role is pivotal in upholding the standards for existing product lines.

The incumbent must possess a comprehensive grasp of regulatory mandates spanning various jurisdictions and territories. Additionally, proficiency in navigating Quality Management Systems (QMS) is essential to support diverse product portfolios across various classifications.

Key Responsibilities:

  • Take charge of the supplier oversight process, encompassing the formulation and execution of supplier assessment schedules such as Quality Technical Agreements and audit timetables.
  • Lead external audits and oversee the execution of resulting action plans to fruition.
  • Initiate and manage Corrective and Preventive Action (CAPA), Non-Conformance (NC), and change control processes, including conducting thorough investigations to identify root causes.
  • Ensure that Quality System procedures are efficient, compliant, user-friendly, and comprehensively understood across the organisation.
  • Develop and maintain Technical Files for Class I and II devices compliant with the Medical Device Regulation (MDR) and UK Conformity Assessed (UKCA) standards.
  • Handle medical device dossier submissions and liaise with Notified Bodies (NBs) and Health Authorities (HAs).
  • Collaborate with Research and Development teams in the design of new products and the modification/extension of existing product lines.
  • Conduct post-market surveillance activities, including clinical follow-ups and periodic safety reporting.
  • Define regulatory strategies for both domestic and international markets.
  • Ensure adherence to relevant domestic and international standards, such as ISO 13485, MDD 93/42/EEC, FDA CFR 21, MDR EU 2017/745, and UK MDR 2022 SI 618.
  • Offer expert guidance, assistance, and training on matters of quality and compliance to functional departments.
  • Promote a culture of compliance throughout the organisation.
  • Champion continuous improvement efforts and the dissemination of best practices.

Requirements:

  • Possession of a degree in Life Sciences or Regulatory Sciences.
  • Previous experience in roles within the Quality Management domain.
  • Previous experience in Regulatory Compliance roles.
  • Familiarity with medical devices, gained through either quality assurance or regulatory affairs positions.
  • Proficiency in working within and overseeing quality frameworks such as ISO 13485 and ISO 9001.
  • Exposure to and familiarity with the Medical Device Regulation (MDR).
  • External Lead Auditor certification (Desirable).
  • Experience with sterile product lines (Desirable).
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