Senior Regulatory Affairs Specialist
1 month ago
Senior Regulatory Affairs Specialist – Medical Devices & IVD's
Oxfordshire, UK – Office based
Up to £60,000 + benefits
This is an excellent opportunity to join a leading medical device manufacturing that is the world leader in Glucose Monitoring, their ranging product portfolio, develops and manufactures glucose monitoring systems for use in both home and hospital settings.
With a diverse, global network serving customers in more than 160 countries, the organisation creates new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, the business is advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The business currently has one open positions as a Senior Regulatory Affairs Specialist who will be responsible for planning, creating, and implementing solutions for regulatory registration and release of products for distribution into specific geographies.
Key Responsibilities
· Lead processes and team involved with obtaining and maintaining product registration, release authorization, and release of products to specified geographies.
· Driving new registrations in the UK, EU, Middle East, and Pakistan regions.
· Drive regulatory strategies including working cross-functionally with other departments to ensure the right strategy is defined.
· Provide training and mentoring to junior colleagues with the scope to get into line management depending on the individual's preference.
· Interact with notified bodies and keep well-versed in global regulations.
Requirements
· University degree in a scientific subject, such as Biomedical science, Chemistry, Pharmacy, Engineering, or equivalent experience.
· Experience working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC), and/or the IVD Directive (98/79/EC).
· Minimum of 4 to 5 years post-qualification experience in regulatory affairs, quality or R&D in the medical device and/or pharmaceutical industry in product registration, medical device file, and/or technical compliance activities.
Due to the organisation's rapid growth, there is extensive opportunity to grow and develop within the company. In addition to a competitive salary, the organsiation offers a highly attractive benefits package that includes a defined-contribution pension scheme, a share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme that you can tailor to your own requirements.
If you are interested in this role or would like more details please email your CV
-
Regulatory Affairs Specialist
6 hours ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company that specializes in the development and commercialization of innovative sequencing technologies. As a Post Market Surveillance Manager, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesCoordinate post-market surveillance...
-
Regulatory Affairs Director
5 hours ago
Oxford, Oxfordshire, United Kingdom SciPro Full time**About SciPro**We are a leading provider of innovative medical solutions, specializing in AI-powered imaging biomarkers. As an exclusive partner of Brainomix, we are committed to delivering high-quality products that meet the highest regulatory standards.**Job Summary**We are seeking a highly experienced Senior Quality Assurance Manager to join our team. As...
-
Regulatory Affairs Manager
8 hours ago
Oxford, Oxfordshire, United Kingdom SciPro Full timeSciPro is proud to be an exclusive partner of Brainomix, a renowned business specializing in AI-powered imaging biomarkers. To facilitate their journey of growth, they are seeking a Senior Quality/Regulatory Manager to oversee a team of 5, who is able to promote collaboration rather than adopting a dictatorial approach. The ideal candidate will have a...
-
Senior Director, Regulatory Affairs
1 month ago
Oxford, Oxfordshire, United Kingdom Cpl Full timeJob Title: Senior Director, Regulatory Affairs Location: Oxfordshire, United Kingdom Salary: Attractive salary plus benefits package (stock options, car allowance, bonus)Job Type: Full time, permanent positionWorking for one of the industry's most innovative clinical stage biotechnology companies, this is a fantastic opportunity to provide expert regulatory...
-
Director of Regulatory Affairs
1 month ago
Oxford, Oxfordshire, United Kingdom Cpl Full timeJob Title: Director of Regulatory Affairs (CMC)Location: Oxfordshire, United Kingdom Salary: Attractive salary plus benefits package (stock options, car allowance, bonus)Job Type: Full time, permanent positionWorking for one of the industry's most innovative clinical stage biotechnology companies, this is a fantastic opportunity to provide expert regulatory...
-
Public Affairs Specialist
5 hours ago
Oxford, Oxfordshire, United Kingdom Membership Bespoke Full timeAbout the RoleWe are seeking a highly motivated and detail-oriented Policy Assistant to join our team at Membership Bespoke. As a Policy Assistant, you will play a key role in supporting our client, a well-respected trade association, in monitoring, researching, and communicating on public policy, political, and other issues impacting the sector.Key...
-
Senior Quality Assurance Manager
5 hours ago
Oxford, Oxfordshire, United Kingdom SciPro Full time**About SciPro**We are a leading provider of innovative medical solutions, specializing in AI-powered imaging biomarkers. As an exclusive partner of Brainomix, we are committed to delivering high-quality products that meet the highest regulatory standards.**Job Summary**We are seeking a highly experienced Senior Quality Assurance Manager to join our team. As...
-
Senior Quality Assurance Manager
5 hours ago
Oxford, Oxfordshire, United Kingdom SciPro Full timeSciPro is proud to be an exclusive partner of Brainomix, a renowned business specializing in AI-powered imaging biomarkers. To facilitate their journey of growth, they are seeking a Senior Quality/Regulatory Manager to oversee a team of 5, who is able to promote collaboration rather than adopting a dictatorial approach. The ideal candidate will have a...
-
Quality and Compliance Manager
7 hours ago
Oxford, Oxfordshire, United Kingdom SciPro Full timeSciPro is proud to be an exclusive partner of Brainomix, a renowned business specializing in AI-powered imaging biomarkers. To facilitate their journey of growth, they are seeking a Senior Quality/Regulatory Manager to oversee a team of 5, who is able to promote collaboration rather than adopting a dictatorial approach. The ideal candidate will have a...
-
Post Market Surveillance Manager
1 month ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeOxford Nanopore Technologies is headquartered at the Oxford Science Park outside Oxford, UK, with satellite offices and a commercial presence in many global locations across the US, APAC and Europe.Oxford Nanopore employs from multiple subject areas including nanopore science, molecular biology and applications, informatics, engineering, electronics,...
-
Regulatory Compliance Engineer
3 weeks ago
Oxford, Oxfordshire, United Kingdom Newton Colmore Consulting Ltd Full timePosition: Quality Assurance Engineer We are seeking a dedicated Quality Assurance Engineer to join our innovative medical device start-up. This organization is at the forefront of developing groundbreaking medical technologies that significantly enhance patient outcomes. In this role, you will work closely with the Quality Assurance Manager and collaborate...
-
Regulatory Compliance Associate
7 hours ago
Oxford, Oxfordshire, United Kingdom Hobson Prior Full timeJob OverviewHobson Prior is seeking a highly skilled Quality Control Specialist to join our team in a Quality Control Analytical Laboratory setting. The successful candidate will be responsible for performing quality control testing in accordance with standard procedures and guidelines.This role may also involve overseeing the work of other staff members in...
-
Post Market Surveillance Coordinator
6 hours ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company that specializes in the development and commercialization of innovative sequencing technologies. Our company is headquartered at the Oxford Science Park, with satellite offices and a commercial presence in many global locations.We employ a diverse team of experts from various...
-
Senior Critical Care Specialist
3 weeks ago
Oxford, Oxfordshire, United Kingdom Oxford University Hospitals Full timePosition Overview The Role The Senior Critical Care Specialist will operate within the medical rota to deliver care to patients experiencing critical health challenges in the Cardiothoracic Intensive Care Unit. This advanced position requires the individual to ensure consistent and high-quality management for patients in critical care and those experiencing...
-
Regulatory Compliance Officer
8 hours ago
Oxford, Oxfordshire, United Kingdom Oxford Biomedica Full timeAbout the Role:Oxford Biomedica is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and processes.Key Responsibilities:Quality Management: Develop and implement quality management systems to ensure compliance with...
-
Data Development Specialist
4 hours ago
Oxford, Oxfordshire, United Kingdom Hays Specialist Recruitment Limited Full timeAbout Our Client Hays Specialist Recruitment Limited is proud to partner with a leading investment firm based in Oxford, UK. This innovative company invests in early-stage businesses across the UK, supporting them to expand into international markets with high growth potential. Our Client's Focus They specialize in the future of UK technology, particularly...
-
Associate Director, Government Relations
5 days ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob SummaryThe Government Affairs Director will support the Corporate Affairs team by driving global government relations, while also contributing to the wider work of the team in corporate communications and internal communications. This role will focus on informing, uniting, and protecting the company's interests, aligning with Oxford Nanopore...
-
Senior Medical Writer
3 weeks ago
Oxford, Oxfordshire, United Kingdom RBW Consulting Full timeA successful independent agency has an opening for a Senior Medical Writer to join their collaborative team in Oxford.As specialists in traditional medical communications, this well-established agency develops global campaigns for top pharmaceutical companies, across a spread of interesting therapeutic areas. Their capabilities include medical affairs,...
-
Post-Market Surveillance Lead
3 weeks ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeAbout Oxford Nanopore Technologies Oxford Nanopore Technologies is a pioneering company at the forefront of genomic analysis, with a commitment to innovation and excellence in the field of life sciences. Our headquarters are located in a dynamic environment, and we have a presence in various global markets, including the US, APAC, and Europe. Our team is...
-
Quality Assurance Manager
4 hours ago
Oxford, Oxfordshire, United Kingdom Oxford Nanopore Technologies Full timeJob DescriptionOxford Nanopore Technologies is a leading biotechnology company that specializes in the development and commercialization of innovative sequencing technologies. As a Post Market Surveillance Manager, you will play a critical role in ensuring the quality and safety of our products.Key ResponsibilitiesCoordinate post-market surveillance...