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Regulatory Affairs Team Lead

3 months ago

Glasgow, Glasgow City, United Kingdom FPSG Full time

Team Lead Regulatory Affairs

Glasgow - Medical Devices

Job Profile


FPSG Life Sciences is working with a leading medical device company looking to recruit a Team Lead in Medical Affairs.

Due to continued growth they are expanding their regulatory Affairs team.

Key Duties:

  • Preparation of

Regulatory Documentation:
Lead the preparation and submission of regulatory documentation and compliance with relevant regulations and standards.

  • Development of Regulatory Plans/Strategies: Develop and implement regulatory plans and strategies for new product development projects and changes to existing products, collaborating closely with crossfunctional teams to ensure alignment with business objectives and regulatory requirements.
  • Participation in Design Control and

Risk Management Activities:

Participate in Design Control and Risk Management activities throughout the product lifecycle, ensuring regulatory requirements are addressed and mitigated appropriately to support product safety and efficacy.


  • Production and Review of Design Dossiers and

Technical Files:
Oversee the production and review of design dossiers, technical files, and change assessments

  • Regulatory Compliance Monitoring: Stay abreast of regulatory developments and changes in the medical device industry, monitoring changes to regulations, standards, and guidelines

Qualifications:

  • Bachelor's degree in a scientific or discipline;
  • Minimum of 4 years of experience in regulatory affairs within the regulatory scientific industry
  • Demonstrated expertise in developing and executing regulatory strategies for new product development and changes to existing products.
  • Excellent leadership and interpersonal skills, with the ability to lead and motivate crossfunctional teams and drive results in a matrixed environment.
  • Exceptional written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to diverse audiences.
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