Regulatory Affairs Specialist

14 hours ago


Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time

Job Title: Quality & Regulatory Affairs Specialist

Job Type: Permanent position

Location: Outskirts of Edinburgh (Hybrid, 3x a week in the office)

Remuneration: Up to £50,000 + Benefits

Cpl 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 responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes in compliance with established quality management systems.

Key Responsibilities:

  • Preparing and compiling regulatory documentation, coordinating and executing regulatory submissions in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Medical Device Approvals (510(k)), and other country requirements as appropriate.
  • Advising staff and project team members on data and information required for successful license applications and coordinating their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
  • Ensuring Quality Assurance release of incoming goods, intermediate, and final product obligations for Cpl Life Sciences.
  • Ensuring Post-market surveillance obligations.
  • Ensuring Vigilance reporting obligations.
  • Being a point of contact for regulatory & quality compliance issues.
  • Interfacing with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting).
  • Evaluating Product/Processes Non-Conformances, determining whether they need to be reported to the Competent Authorities.
  • Supporting QMS organization during regulatory inspections or certifications audits.
  • Performing any other duties as reasonably requested from the Company from time to time.
  • Conducting all duties in compliance with company Quality Management System and cGMP, GCP, and ISO13485 requirements.

Requirements:

  • Master's degree or equivalent in life sciences and 3/5 years of experience in a regulatory/quality role.
  • Level required in the function (e.g., validation, finance, quality control)
  • Experience in the medical device / IVD / biotech industry
  • Experienced in meeting with, making presentations to, and negotiating with regulators.
  • Specific technical competencies required for the role (e.g., GMP, GLP exposure, FDA exposure, IT packages, technical writing skills) Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, CMDR, etc.).
  • Specialist knowledge of vigilance processes for US, EU, and other jurisdictions as appropriate (MDR, MEDDEV 2.12, etc.)

For more information, please contact us.



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

    Job Title: Quality and Regulatory Affairs SpecialistJoin 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...


  • 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 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...