Medical Device Regulatory Expert
3 weeks ago
Cpl 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 Responsibilities:- Prepare and compile regulatory documentation, coordinating submissions 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 as necessary.
- Advise staff and project team members on data and information required for successful license applications.
- Contribute to the regulatory watch process by maintaining knowledge of new or updated regulatory requirements, guidance documents, and industry standards.
We require a candidate with a relevant degree and/or experience in a regulatory affairs environment. Previous experience preparing and submitting BLA, 510(k), PMA, CE mark, and technical files to worldwide regulatory authorities is essential.
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Medical Device Regulatory Expert
6 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 Coordinator
3 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full timeCpl 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...
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Compliance Officer
5 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 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
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 Affairs Specialist
6 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 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 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 Compliance Specialist
6 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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Compliance and Licensing Expert
4 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full timeAbout the RoleWe are seeking a highly skilled Compliance and Licensing Expert to join our growing Regulatory Affairs Department at Cpl Life Sciences. This is a full-time, permanent position offering a salary of £35,000 to £40,000 + benefits. The role is based in the outskirts of Edinburgh, Scotland, UK and requires occasional travel to site.The successful...
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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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Global Regulatory Manager
4 weeks ago
Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full timeJob DescriptionWe are seeking a Global Regulatory Manager to join our team at Cpl Life Sciences. This is a full-time, permanent position offering a salary of £35,000 to £40,000 + benefits. The role is based in the outskirts of Edinburgh, Scotland, UK and requires occasional travel to site.The successful candidate will be responsible for managing product...
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Regulatory Policy Advisor for Medical Devices
2 weeks ago
Edinburgh, Edinburgh, United Kingdom Hobson Prior Full timeJob Summary:Hobson Prior seeks a dedicated Regulatory Affairs Specialist to work in Edinburgh. This role involves preparing regulatory documents, submitting applications, and maintaining compliance with regulatory standards.Main Responsibilities:Develop and submit regulatory documents for approval in multiple countries.Support team members with data and...
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Regulatory Affairs Specialist
3 weeks ago
Edinburgh, Edinburgh, United Kingdom SRG Full timeJob OverviewSRG is seeking a skilled Regulatory Affairs Specialist to join our team. As a crucial member of the regulatory affairs function, you will be responsible for developing and implementing global regulatory strategies to ensure compliance with relevant regulations.The successful candidate will have a scientific degree and previous regulatory...
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Device Reliability Modeling Expert
5 days ago
Edinburgh, Edinburgh, United Kingdom Cirrus Logic Full timeCirrus Logic is a leading company in mixed-signal processing, and we are seeking an expert in device reliability modeling to join our team. The ideal candidate will have a Ph.D. in Electrical Engineering or Physics, or a Master's degree with 3+ years of experience.Job DescriptionThe successful candidate will be responsible for maintaining device lab...
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Quality Management Expert
5 days ago
Edinburgh, Edinburgh, United Kingdom Clinical Professionals Limited Full timeAbout Us:Clinical Professionals Limited is a leading provider of clinical research services. We offer a range of solutions to support the development and approval of medical devices.The Job:We are seeking an experienced Quality & Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring that our medical devices...
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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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Compliance Officer
3 weeks ago
Edinburgh, Edinburgh, United Kingdom SRG Full timeAbout the RoleThis exciting opportunity has arisen for a Compliance Officer - Global Regulatory to join SRG. You will play a key role in ensuring that all products comply with relevant regulatory requirements worldwide.We are looking for someone with a strong understanding of regulatory affairs, preferably with experience in medical devices or...
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Biotechnology Regulatory Specialist
5 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...