
Medical Device Regulatory Coordinator
3 weeks ago
Cpl Life Sciences is seeking a talented Medical Device Regulatory Coordinator to join our team. This role is based in the outskirts of Edinburgh, Scotland, UK, with 3x a week on-site requirement, offering an estimated salary of £35,000 to £40,000 + benefits.
As a Medical Device Regulatory Coordinator, you will be responsible for managing product license registration with regulatory authorities worldwide, preparing and submitting documentation, and maintaining registrations/licences. Key responsibilities include:
- Preparing and compiling regulatory documentation in compliance with ISO13485, IVD 2017/746 Regulation, FDA 21 Code of Federal Regulations (CFRs), Biologics License Applications (BLA), Medical Device Approvals (510(k)), Canadian Medical Device Regulations (CMDR) – Part 1, and other country requirements.
- Coordinating and executing regulatory submissions for countries including US, EU, Canada, and others, ensuring compliance with relevant regulations.
- Advising staff and project team members on data and information required for successful license applications, coordinating their efforts to ensure high-quality submissions.
- Developing product labelling regulatory requirements for products and customer-contracted products, including package labels, product labels, and instructions for use.
- Liaising with internal and external parties to support product labelling development.
- Maintaining knowledge of new or updated regulatory requirements, guidance documents, and industry standards through regular regulatory watch activities.
- Ensuring maintenance of product regulatory documents and technical files for ongoing compliance with relevant regulations.
- Providing support to the Department Leader of Regulatory Affairs regarding planning, coordination of activities, training, and supervision of junior staff.
This role requires a relevant degree and/or experience in a regulatory affairs environment, as well as expertise in vigilance processes for US, EU, and other jurisdictions. Previous experience preparing and submitting BLA, 510(k), PMA, CE mark, and technical files to worldwide regulatory authorities is also essential.
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Medical Device Regulatory Expert
5 days ago
Edinburgh, Edinburgh, United Kingdom Clinical Professionals Limited Full timeJob Description:Clinical Professionals Limited is seeking a Medical Device Regulatory Expert to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements and standards.The ideal candidate will have a strong background in medical device regulation and a proven track record of...
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Medical Device Regulatory Expert
3 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full timeJob DescriptionCpl Life Sciences is an established IVD manufacturer seeking a highly skilled Regulatory Affairs Officer to manage product licenses and ensure compliance with international regulations. This role offers an exciting opportunity to join a growing department and support our growth as a leading company in the life sciences industry.Main...
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Compliance Officer
4 days ago
Edinburgh, Edinburgh, United Kingdom SRG Full timeAbout the JobWe are seeking a highly skilled Compliance Officer - Medical Devices to join our team in the Edinburgh area. As a key member of the team, you will be responsible for ensuring the ongoing compliance of product regulatory documents and technical files.Responsibilities:Develop and maintain product labelling regulatory requirements.Contribute to the...
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Global Regulatory Lead
3 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time**About the Role:** We are seeking a highly skilled Medical Device Compliance Officer to join our Regulatory Affairs Department. In this role, you will be responsible for ensuring the compliance of our medical devices with global regulatory requirements.**Key Responsibilities:Preparing and compiling regulatory documentation in compliance with ISO13485, IVD...
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Regulatory Affairs Specialist
3 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full timeJob OverviewCpl Life Sciences is seeking a highly skilled Regulatory Affairs Officer to join our team. As a key member of our IVD manufacturer, you will be responsible for managing product license registration with regulatory authorities worldwide.About the RoleThis is an exciting opportunity to work in a growing department and support our efforts in...
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Regulatory Compliance Specialist
5 days ago
Edinburgh, Edinburgh, United Kingdom Clinical Professionals Limited Full timeJob Summary:We are seeking a highly skilled Regulatory Compliance Specialist to join our team at Clinical Professionals Limited. This is a full-time, permanent position that requires strong knowledge of regulatory requirements and processes.The successful candidate will have experience in implementing and maintaining regulatory compliance processes,...
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Regulatory Affairs Specialist
5 days ago
Edinburgh, Edinburgh, United Kingdom Clinical Professionals Limited Full timeJob Title: Quality & Regulatory Affairs SpecialistLocation: Outskirts of Edinburgh (Hybrid, 3x a week in the office)About the Role:We are seeking an experienced Quality & Regulatory Affairs Specialist to join our growing team at Clinical Professionals Limited. As a key member of our department, you will be responsible for ensuring that our medical devices...
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Regulatory Affairs Specialist
3 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full timeCompany Overview:Cpl Life Sciences is an established and growing IVD manufacturer, offering an exciting opportunity to join our team as a Regulatory Affairs Officer.About the Role:We are seeking a highly skilled Regulatory Affairs Officer to manage product license registration with regulatory authorities worldwide. The successful candidate will prepare and...
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Regulatory Affairs Professional
4 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full timeJob Title: Regulatory Affairs ProfessionalAt Cpl Life Sciences, we are seeking an experienced Regulatory Affairs Professional to join our team. This is a full-time position based on the outskirts of Edinburgh, Scotland, UK, requiring 3 days of site work per week.The estimated salary for this role is £38,500 - £43,000. We offer relocation support for the...
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Regulatory Affairs Specialist
3 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time**Job Title:** Regulatory Affairs Specialist**Salary Range:** £35,000 - £40,000 + benefitsCpl Life Sciences is seeking a highly skilled Regulatory Affairs Specialist to support the growth of our IVD manufacturing team. As a key member of our Regulatory Affairs Department, you will be responsible for managing product license registrations with global...
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Regulatory Affairs Specialist
4 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full timeJob SummaryAn exciting opportunity has arisen for a Regulatory Affairs Specialist to join our team at Cpl Life Sciences. This is a full-time, permanent position that offers a salary of £35,000 to £40,000 + benefits. The role is based in the outskirts of Edinburgh, Scotland, UK and requires travel to site 3 times a week.The successful candidate will be...
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Regulatory Affairs Specialist
3 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full timeAn exciting opportunity to work with Cpl Life Sciences as a Regulatory Affairs Specialist. This role is based in the outskirts of Edinburgh, Scotland, UK, with 3x a week on-site requirement. The estimated salary for this position is £35,000 to £40,000 + benefits.The successful candidate will be responsible for managing product license registration with...
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Biotechnology Regulatory Specialist
4 days ago
Edinburgh, Edinburgh, United Kingdom SRG Full timeAbout the CompanyS RG is a leading Biotechnology company based in the Edinburgh area, seeking a highly skilled Biotechnology Regulatory Specialist to join their team on a permanent basis.Job Description:You will be responsible for developing product labelling regulatory requirements, coordinating and executing regulatory submissions, and contributing to the...
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Regulatory Affairs Specialist
3 weeks ago
Edinburgh, Edinburgh, United Kingdom SRG Full timeJob Title: Regulatory Affairs SpecialistEstimated Salary: £45,000 - £60,000 per annum.SRG is seeking a highly skilled Regulatory Affairs Specialist to join their team in Edinburgh. The successful candidate will be responsible for building regulatory strategies, determining applicable regulations, and managing product license registrations worldwide.Key...
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Regulatory Affairs Specialist
3 weeks ago
Edinburgh, Edinburgh, United Kingdom Clinical Professionals Limited Full timeJob Title: Quality Compliance OfficerLocation: Outskirts of Edinburgh (Hybrid, 3x a week in the office)An exciting opportunity has arisen to support a growing Regulatory Affairs Department at an established IVD manufacturer. As a Quality Compliance Officer, you will be responsible for delivering the end-to-end regulatory package under ODM-Distributor scheme...
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Regulatory Affairs Specialist
3 weeks ago
Edinburgh, Edinburgh, United Kingdom SRG Full timeCompany Overview: SRG is a leading Biotechnology company based in Edinburgh, Scotland. We are seeking an experienced Regulatory Affairs Officer to join our team on a permanent basis.Salary: £55,000 - £65,000 per annum depending on experience.Job Description:We are looking for a skilled Regulatory Affairs Officer to build regulatory strategy, determine...
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Regulatory Affairs Professional
5 days ago
Edinburgh, Edinburgh, United Kingdom SRG Full timeAbout the RoleThe SRG is looking for a highly skilled Regulatory Affairs Professional to join their team in the Edinburgh area. As a key member of the team, you will be responsible for preparing and compiling regulatory documentation, coordinating and executing regulatory submissions for countries including US, EU, Canada, and other territories as...
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International Regulatory Manager
3 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full timeAbout the Role:We are seeking a highly skilled Regulatory Affairs Officer to join our team at Cpl Life Sciences.Job Responsibilities:The successful candidate will be responsible for:Managing product license registration with regulatory authorities worldwide.Preparing and compiling regulatory documentation, coordinating submissions, and advising staff on data...
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Regulatory Affairs Specialist
3 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join Cpl Life Sciences in Edinburgh, Scotland. This is a full-time, permanent position requiring 3x weekly on-site presence.Compensation: £45,000 per annum + benefits package.The successful candidate will play a crucial role in supporting our growing Regulatory Affairs Department...
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Compliance Specialist
2 weeks ago
Edinburgh, Edinburgh, United Kingdom SRG Full timeJob SummarySRG is seeking a highly skilled Regulatory Affairs Officer to join their team in the Edinburgh area. This is a permanent, full-time position offering a salary of £45,000 per annum.About the RoleThe successful candidate will be responsible for preparing and compiling regulatory documentation, coordinating and executing regulatory submissions for...