Regulatory Affairs Expert

5 days ago


Edinburgh, Edinburgh, United Kingdom Cpl Healthcare Full time

Job Title: Regulatory Affairs Officer – Post Market Surveillance

Cpl Healthcare is seeking a highly skilled Regulatory Affairs Officer to join our team based near Edinburgh. As a key member of our Regulatory Affairs team, you will be responsible for building regulatory strategy, determining applicable regulatory requirements, and proposing solutions to comply with these regulations.

Key Responsibilities:

  • Regulatory Strategy and Compliance
    • Determine and implement regulatory strategies to ensure compliance with ISO13485, IVD Directive 98/79/EC, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Canadian Medical Device Regulations (CMDR) – Part 1, and other country requirements as appropriate.
    • Prepare and compile regulatory documentation, coordinate and execute regulatory submissions for countries including the US, EU, Canada, and any other territories as necessary.
  • Documentation and Reporting
    • Develop product labeling regulatory requirements for products and customer contracted products, including package labels, product labels, and instructions for use.
    • Assist in the development of regulatory reports and filings, ensuring coherence and accuracy.
  • Liaison and Communication
    • Liaise with regulatory authorities and external contract bodies, providing specialized information as required.
    • Collaborate with staff and project team members to ensure successful license applications and regulatory submissions.

Requirements:

  • A relevant degree and/or relevant work experience in a regulatory affairs environment.
  • Previous post-market regulatory surveillance experience (BPDR submission, NDR submission, and FSCA).
  • Experience working within an FDA licensed manufacturing facility.
  • Ability to prepare coherent regulatory reports and filings.

Benefits:

  • Competitive salary: £35,000 - £37,000 per annum, plus benefits.
  • Flexible working environment where applicable.
  • A range of core and flexible benefits, including pension, private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days, and access to marketplace discounts.

Please note that you must have the full right to work in the UK and be able to work on-site 3 times a week.



  • Edinburgh, Edinburgh, United Kingdom Cpl Healthcare Full time

    Regulatory Affairs Officer RoleCpl Healthcare is seeking a skilled Regulatory Affairs Officer to support our growing Regulatory Affairs Department. As a key member of our team, you will be responsible for building regulatory strategy, determining applicable regulatory requirements, and proposing solutions to comply with regulatory requirements. Your...


  • Edinburgh, Edinburgh, United Kingdom Cpl Healthcare Full time

    Regulatory Affairs ConsultantWe are seeking a highly skilled Regulatory Affairs Consultant to join our Regulatory Affairs team based near Edinburgh. The purpose of the role is to develop and implement regulatory strategies to ensure compliance with national and international regulations.Main Responsibilities:Develop and maintain regulatory documentation to...


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

    Job Title:Quality and Compliance Regulatory AffairsJob Type:Permanent position Edinburgh (Hybrid, 3x a week in the office)Compliance and Regulatory Affairs Specialist responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes in compliance with established quality management systems.Key responsibilities include:Initial...


  • Edinburgh, Edinburgh, United Kingdom Cpl Healthcare 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 + 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...


  • Edinburgh, Edinburgh, United Kingdom NHS Scotland Full time

    NHS Scotland seeks a highly skilled Regulatory Affairs Coordinator to join our team.The estimated annual salary for this position is £25,000 - £38,000, dependent on qualifications and experience.We pride ourselves on being an equal opportunities employer and are dedicated to providing a supportive work environment for all employees.This role involves...


  • Edinburgh, Edinburgh, United Kingdom Cpl Healthcare Full time

    About the RoleAs a Regulatory Affairs Specialist, you will play a crucial part in maintaining product and site regulatory & quality compliance to ensure license/registration is maintained once granted. This role reports to the Chief Regulatory Affairs and Quality Officer and oversees end-to-end regulatory packages under ODM-Distributor schemes, ensuring...


  • 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...


  • Edinburgh, Edinburgh, United Kingdom TargetJobs UK Full time

    The FCA's Graduate Programme offers a chance to join our dynamic teams and shape the future of financial regulation. As a Regulatory Affairs Specialist, you'll work closely with experts to monitor sectors, deliver policy insights, and explore risks within firms.About the FCAWe regulate the financial industry, ensuring consumer protection and market...


  • Edinburgh, Edinburgh, United Kingdom ESS Recruit Full time

    About the JobWe are recruiting for a Medical Devices Regulatory Expert to join our team in Edinburgh. As a key member of our Regulatory Affairs & Quality team, you will be responsible for ensuring compliance with international regulations and standards for medical devices.Key ResponsibilitiesDevelop and implement regulatory strategies for medical...


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

    Estimated Salary: £50,000 - £70,000 per annumAbout the RoleClinical Professionals Limited is seeking an experienced Regulatory Affairs and Quality Assurance Specialist to join our team in Edinburgh.Job DescriptionWe are looking for a highly skilled individual to support our growing Regulatory Affairs Department. As a Regulatory Affairs and Quality...


  • Edinburgh, Edinburgh, United Kingdom SRG Full time

    SRG is seeking a highly skilled Regulatory Affairs Specialist to join their team in Edinburgh. The successful candidate will be responsible for implementing and maintaining regulatory compliance processes, including regulatory evaluation of non-conformances, post-market surveillance, vigilance, and associated reporting.Key Responsibilities:Act as the main...


  • Edinburgh, Edinburgh, United Kingdom ESS Recruit Full time

    Job OverviewEducational Services Scotland's client is a well-established bio-manufacturing organisation, with an internationally recognised product portfolio. They offer contract services to the bioscience industry and manufacture products for major global players in the Life Sciences sectors.ResponsibilitiesDevelop regulatory strategies and manage product...


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

    Job Title: Regulatory Affairs ConsultantJob Type: ContractLocation: Outskirts of Edinburgh, Scotland, UKThe role is a full-time, permanent position working 37 hours a week. The purpose of the role is to implement and maintain regulatory compliance processes, including regulatory evaluation of non-conformances, post market surveillance, vigilance and...


  • Edinburgh, Edinburgh, United Kingdom Faculty of Advocates Full time

    Esteemed Regulatory Affairs Professional sought by the Faculty of Advocates to assume a pivotal role in ensuring compliance and governance excellence.About the RoleThe ideal candidate will possess a strong background in regulatory affairs, with at least five years' experience working with confidential data and administrative office skills. A minimum of two...


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

    Job Title: Quality and Compliance OfficerJob Type: PermanentLocation: Outskirts of Edinburgh (Hybrid, 3x a week in the office)At Clinical Professionals Limited, we are seeking a highly skilled Quality and Compliance Officer to join our team. As a key member of our Regulatory Affairs Department, you will be responsible for delivering the end-to-end regulatory...


  • Edinburgh, Edinburgh, United Kingdom Lorien Full time

    About the RoleLorien is looking for a highly skilled Regulatory Affairs Specialist to join their team on a contract basis. The ideal candidate will have excellent communication skills and experience of policy development which considers legal requirements.This role is working 4 days per week on a hybrid basis and will be partially based in Edinburgh offices....


  • Edinburgh, Edinburgh, United Kingdom IQVIA Full time

    Job Title: Regulatory Affairs Director for Global ComplianceCompany Overview:IQVIA Laboratories is a global leader in drug discovery and development laboratory services, offering a comprehensive suite of central laboratory and specialty biomarker services.Estimated Salary:$120,000 - $180,000 per year, depending on experience.Job Description:This...


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

    Job Title: Medical Devices Regulatory Analyst Job SummaryClinical Professionals Limited is seeking a highly skilled Medical Devices Regulatory Analyst to join their team. As a key member of the regulatory affairs department, you will be responsible for implementing and maintaining regulatory compliance processes. About the RoleThis full-time position...


  • Edinburgh, Edinburgh, United Kingdom Royal London Full time

    Regulatory Law Specialist OpportunityWe are seeking an experienced and skilled Solicitor to join our team as a Senior Legal Counsel in Edinburgh, London, or Macclesfield. This role will provide strategic legal advice, guidance, and support across the Royal London Group.As a Senior Legal Counsel, you will be responsible for providing expert legal advice and...


  • Edinburgh, Edinburgh, United Kingdom Modulr Full time

    Role DescriptionThis Regulatory Framework Expert role is a key position within our Partner Oversight team, responsible for ensuring our partners comply with regulatory requirements. As a Regulatory Framework Expert, you will have the opportunity to develop your skills and knowledge in this area, working closely with our partners to achieve joint objectives...