Quality Assurance Manager

1 month ago


Edinburgh, Edinburgh, United Kingdom SRG Full time

Join SRG, a prominent Biotechnology company in Edinburgh, as a Senior Regulatory Compliance Officer. This exciting opportunity comes with an estimated annual salary range of £60,000-£70,000.

About the Opportunity

This senior position demands a high level of expertise in regulatory affairs, with a focus on delivering comprehensive regulatory packages and ensuring seamless integration with quality management systems. Key responsibilities include:

  • Managing regulatory documentation and submissions, adhering to relevant regulations like ISO 13485, IVD 2017/746, and FDA 21 CFR.
  • Collaborating with cross-functional teams to gather necessary data and information for regulatory applications, guaranteeing high-quality submissions.
  • Overseeing the quality assurance process, including supplier management, product testing, and certification.
  • Acting as the primary point of contact for regulatory and quality-related matters.
  • Reporting incidents and safety actions to competent authorities, including FSCA, FSN, and MDRs.
  • Assisting with quality management system implementation and internal audits.
  • Maintaining up-to-date knowledge of relevant regulations, company policies, and procedures related to cGMP, GCP, and ISO 13485.
Requirements and Qualifications

Candidates should have a scientific degree, substantial experience in regulatory affairs, and a proven track record of delivering high-quality regulatory submissions. Strong knowledge of applicable regulations, such as those governing medical devices and biologics, is essential for success in this challenging role.



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