Quality and Regulatory Affairs Senior Manager

3 weeks ago


Liverpool, Liverpool, United Kingdom BioTalent Full time

Quality and Regulatory Affairs Senior Manager

BioTalent is excited to offer an opportunity to become a pivotal member of a prominent healthcare product provider with a significant international footprint across more than 30 nations.

Key Responsibilities

  • Serve as the EU Responsible Person concerning MHRA licenses classified as WDA and Home Office Licenses, acting as the primary liaison for the MHRA.
  • Supervise the upkeep of the Quality Management System (QMS).
  • Strategically plan, oversee, and evaluate regulatory affairs initiatives while ensuring adherence to pertinent guidelines and regulations.
  • Manage and uphold ISO certifications along with CE marking compliance.
  • Collaborate with external vendors, contractors, or suppliers.
  • Organize and execute inspections and audits of both the site and external partners.
  • Lead a team of skilled Quality Professionals.

Essential Qualifications and Skills

  • A Bachelor's degree or higher in a Science-related field.
  • Significant experience in Quality Assurance/Regulatory Affairs within the pharmaceutical or medical device sectors.
  • Proven experience as an EU Responsible Person is mandatory.
  • Familiarity with QMS aligned with relevant ISO standards: 9001 or 13485.
  • Exemplary leadership abilities with experience in team management.

Preferred Skills

  • Accredited Auditor Certification is a plus.
  • Solid understanding of Good Distribution Practice (GDP).
  • Knowledge of risk management and applicable standards (ISO 14791).

We are in the process of shortlisting candidates for this role. For further inquiries, please reach out for a confidential discussion.



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