Senior Medical Device Officer

1 month ago


Edinburgh, Edinburgh, United Kingdom SRG Full time

Edinburgh-based SRG is hiring a Senior Regulatory Compliance Officer to oversee regulatory package delivery and ensure quality management system compliance. The estimated annual salary for this position ranges from £58,000 to £68,000.

About the Job

This senior role involves preparing and compiling regulatory documents, coordinating submissions, and ensuring quality assurance release of products. Key responsibilities include:

  • Coordinating regulatory submissions and maintaining compliance with relevant regulations, such as ISO 13485, IVD 2017/746, and FDA 21 CFR.
  • Providing guidance to staff and project team members on necessary data and information for license applications and ensuring their contributions meet submission standards.
  • Overseeing quality assurance processes, including supplier management, incoming inspection, and product release.
  • Serving as a primary point of contact for regulatory and quality compliance matters.
  • Reporting incidents and safety actions to competent authorities, including FSCA, FSN, and MDRs.
  • Supporting quality management system implementation and auditing.
  • Maintaining awareness of company policies and procedures related to cGMP, GCP, and ISO 13485.
What We're Looking For

Candidates should hold a scientific degree and possess significant experience in regulatory affairs within the medical device industry. Familiarity with FDA-approved facilities and a deep understanding of applicable regulations, such as those related to medical devices and biologics, is crucial for success in this role.



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