Regulatory Affairs Specialist

6 days ago


Edinburgh, Edinburgh, United Kingdom Clinical Professionals Limited Full time
Job Title: Quality and Regulatory Affairs Specialist

Join Clinical Professionals Limited as a Quality and Regulatory Affairs Specialist and contribute to the growth of our IVD manufacturer. This exciting opportunity will see you working closely with our Regulatory Affairs Department to deliver end-to-end regulatory packages under ODM-Distributor schemes.

Key Responsibilities:
  • Deliver regulatory packages in compliance with established quality management systems
  • Oversee initial compilation of design control evidences, supplier management, incoming inspection and product release processes
  • Prepare and compile regulatory documentation, coordinating and executing regulatory submissions
  • Advising staff and project team members on data and information required for successful license applications
  • Ensure Quality Assurance release of incoming goods, intermediate, and final product obligations
  • Interfacing with Competent Authorities for reporting incidents and field safety actions
  • Supporting QMS organization during regulatory inspections or certifications audits
Requirements:
  • Master's degree or equivalent in life sciences
  • 3/5 years of experience in a regulatory/quality role
  • Experience in the medical device/IVD/biotech industry
  • Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics
What We Offer:
  • A dynamic and growing IVD manufacturer
  • A collaborative and supportive team environment
  • Opportunities for professional growth and development


  • Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time £50,000

    Job Title: Quality & Regulatory Affairs SpecialistJob Type: Permanent positionLocation: Outskirts of Edinburgh (Hybrid, 3x a week in the office)An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department.The Quality & Regulatory Affairs Specialist is responsible for delivering end-to-end...


  • Edinburgh, Edinburgh, United Kingdom Cpl Healthcare Full time

    Job Title: Quality & Regulatory Affairs SpecialistJob Type: Permanent positionLocation: Hybrid, 3x a week in the officeRemuneration: Up to £50,000 + BenefitsAn exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. Reporting to the Chief Regulatory Affairs and Quality Officer, the...


  • Edinburgh, Edinburgh, United Kingdom Science Solutions Recruitment Full time

    Biocides Regulatory ExpertScience Solutions Recruitment is seeking a highly skilled Biocides Regulatory Affairs specialist to join their team. As a regulatory affairs expert, you will provide scientific and technical input into processes and offer regulatory advice and deliverables to clients.Key Responsibilities:Act as biocide regulatory affairs expert for...


  • Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

    Job Title: Quality & Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Quality & Regulatory Affairs Specialist to join our team at Cpl Life Sciences. As a key member of our Regulatory Affairs Department, you will be responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes, ensuring compliance with...


  • Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

    Job Title: Quality & Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Quality & Regulatory Affairs Specialist to join our team at Cpl Life Sciences. As a key member of our Regulatory Affairs Department, you will be responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes, ensuring compliance with...


  • Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

    Job Title: Regulatory Affairs SpecialistJob Type: Full-timeLocation: Outskirts of Edinburgh, Scotland, UKRemuneration: £37,000 - £40,000 + benefitsThe Regulatory Affairs Specialist will be responsible for implementing and maintaining regulatory compliance processes, including regulatory evaluation of non-conformances, post-market surveillance, vigilance,...


  • Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

    Job Title: Quality & Regulatory Affairs SpecialistJob Type: Permanent positionLocation: Outskirts of Edinburgh (Hybrid, 3x a week in the office)Remuneration: Up to £50,000 + BenefitsCpl Life Sciences is seeking a highly skilled Quality & Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs Department, you will be...


  • Edinburgh, Edinburgh, United Kingdom Clinical Professionals Limited Full time

    Regulatory Affairs Officer – Post-Market SurveillanceJoin Clinical Professionals Limited in a challenging role that requires expertise in regulatory affairs and post-market surveillance. As a Regulatory Affairs Officer, you will be responsible for ensuring compliance with regulatory requirements and maintaining a high level of vigilance in the medical...


  • Edinburgh, Edinburgh, United Kingdom Clinical Professionals Limited Full time

    **Job Title:** Regulatory Affairs Specialist**Job Type:** Contract**Location:** EdinburghWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Clinical Professionals Limited. As a key member of our regulatory team, you will be responsible for implementing and maintaining regulatory compliance processes, including regulatory...


  • Edinburgh, Edinburgh, United Kingdom SRG Full time

    Regulatory Affairs OfficerSRG is seeking a highly skilled Regulatory Affairs Officer to join their team in Edinburgh. As a key member of the team, you will be responsible for ensuring compliance with regulatory requirements and implementing processes to maintain regulatory standards.The Role:Act as the primary point of contact for regulatory compliance...


  • Edinburgh, Edinburgh, United Kingdom SRG Full time

    Regulatory Affairs OfficerSRG is seeking a highly skilled Regulatory Affairs Officer to join their team in Edinburgh. As a key member of the team, you will be responsible for ensuring compliance with regulatory requirements and implementing processes to maintain regulatory standards.The Role:Act as the primary point of contact for regulatory compliance...


  • Edinburgh, Edinburgh, United Kingdom SRG Full time

    Regulatory Affairs OfficerSRG is seeking a highly skilled Regulatory Affairs Officer to join their team in Edinburgh. As a key member of the team, you will be responsible for ensuring the company's compliance with regulatory requirements.Key Responsibilities:Implement and maintain regulatory compliance processes, including regulatory evaluation of...


  • Edinburgh, Edinburgh, United Kingdom SRG Full time

    Regulatory Affairs OfficerSRG is seeking a highly skilled Regulatory Affairs Officer to join their team in Edinburgh. As a key member of the team, you will be responsible for ensuring the company's compliance with regulatory requirements.Key Responsibilities:Implement and maintain regulatory compliance processes, including regulatory evaluation of...


  • Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time £37,000 - £40,000

    Job Title: Regulatory Affairs Compliance OfficerJoin Cpl Life Sciences as a Regulatory Affairs Compliance Officer and take on a challenging role that requires expertise in implementing and maintaining regulatory compliance processes.Key Responsibilities:Implement and maintain regulatory compliance processes, including regulatory evaluation of...


  • Edinburgh, Edinburgh, United Kingdom Cpl Healthcare Full time

    Job Title: Regulatory Affairs OfficerJob Type: Full-time, permanent positionLocation: Outskirts of Edinburgh, Scotland, UKRemuneration: £35,000 to £37,000 + benefitsAn exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. In this role as a Regulatory Affairs Officer, you will be...


  • Edinburgh, Edinburgh, United Kingdom Cpl Healthcare Full time

    Regulatory Affairs OfficerJob Type: Full-time, permanent positionLocation: Outskirts of Edinburgh, Scotland, UKRemuneration: £35,000 to £37,000 + benefitsAn exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department. In this role as a Regulatory Affairs Officer, you will be responsible for...


  • Edinburgh, Edinburgh, United Kingdom SRG Full time

    Regulatory Affairs OfficerSRG is working with a leading Biotechnology company based in the Edinburgh area who are seeking a Regulatory Affairs Officer to join their team on a permanent basis.Key Responsibilities:Implement and maintain regulatory compliance processes, including regulatory evaluation of non-conformances, post-market surveillance, vigilance,...


  • Edinburgh, Edinburgh, United Kingdom SRG Full time

    Regulatory Affairs OfficerSRG is working with a leading Biotechnology company based in the Edinburgh area who are seeking a Regulatory Affairs Officer to join their team on a permanent basis.Key Responsibilities:Implement and maintain regulatory compliance processes, including regulatory evaluation of non-conformances, post-market surveillance, vigilance,...


  • Edinburgh, Edinburgh, United Kingdom Cpl Healthcare Full time

    Job Title: Regulatory Affairs Officer – Post-Market SurveillanceJob Type: 12-Month Fixed-Term ContractLocation: Outskirts of Edinburgh, Scotland, UK – 3x a week on site but could consider a remote profile.The role is a full-time, permanent position working 37 hours a week.The purpose of the role is to implement and maintain regulatory compliance...


  • Edinburgh, Edinburgh, United Kingdom Ramboll Group AS Full time

    Senior Consultant (m/f/d) Chemical Regulatory AffairsWe are seeking a highly skilled and experienced professional to join our Health Sciences department as a Senior Regulatory Affairs Consultant. As a key member of our team, you will be responsible for providing subject matter expertise in chemical legislation, developing authorisation strategies, and...