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Senior Regulatory Affairs Specialist
4 weeks ago
A long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business. Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. They are looking for an individual that is hard working and self-motivated to assist with all things regulatory. Responsibilities will include:
- Provide technical support to the business, suppliers and customers on all matters relating to the safety, legality and quality of the products purchased and sold.
- A clear understanding of the legal requirements for labelling and testing within the required product areas.
- To ensure all products comply with relevant legislation.
- Produce and maintain up to date technical files for medical devices to the required standards.
- Ensure all quality and technical issues relating to technical files are resolved effectively. Escalate when necessary to the Technical Manager/Director
- Assess device related incidents/complaints for medical device reporting requirements. When required, compile and submit reportable events to relevant regulatory authorities in timely manner.
- Review of complaint and other product related information in order to create annual Post Marketing Surveillance report.
- Support the introduction of New products by advising on Regulatory requirements when appropriate.
- Perform Mock recalls as necessary.
- Directly manage the Regulatory Specialist, training and coaching the to assist you in delivering the key Regulatory objectives.
- Deliver key training sessions and provide proactive guidance/input across Sales, Marketing, Procurement and Project Management teams for all Regulatory updates impacting the business, products and processes.
- 3 years experience in Medical devices (class I and IIa).
- Experience in Technical files and Post market surveillance.
- Expert knowledge of MDR, ISO13485, UK MDR.
- Experience interacting with Notified/Approved Body.
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Senior Regulatory Affairs Specialist
1 week ago
Yorkshire, United Kingdom Austin Vita Full timeThe Senior Regulatory Affairs Specialist is responsible for ensuring medical device regulatory compliance with national and international legislation for projects, product and new market clearance. You will manage specific regulatory objectives to meet the companys Strategic Plan and Department Operational Objectives. Assisting and sometimes deputising for...
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Regulatory Affair Specialist
2 weeks ago
South West London, United Kingdom Harrington Recruitment Ltd Full time**The Role** The Regulatory Affairs Specialist will report to the Commercial Director. This is expected to be a hybrid role, 3 days per week working from home and 2 days based South-West London. The person should be located a commutable distance to the office.. Working together with colleagues in Germany, the Regulatory Affairs Specialist will be required...
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Regulatory Affairs Specialist
4 weeks ago
West Yorkshire, United Kingdom X4 Life Sciences Full timeThis range is provided by X4 Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range Direct message the job poster from X4 Life Sciences A long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their...
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Regulatory Affairs Specialist
6 days ago
West Yorkshire, United Kingdom X4 Life Sciences Full timeThis range is provided by X4 Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range Direct message the job poster from X4 Life Sciences A long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their...
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Regulatory Affairs Manager
4 weeks ago
West Midlands, United Kingdom Mosaic Regulatory Solutions Full timeRole- Regulatory Affairs ManagerLocation West Midlands and Remote workingSalary - On ApplicationManagement, review and submission of all post-approval applications required to support the portfolio – including, but not limited to, Type IA, IB & II Variations, BSVs, Renewals, MAH Transfers/COAs, Sunset Clause Notifications/exemptions and MA...
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Regulatory Affairs Manager
3 weeks ago
West Midlands, United Kingdom Mosaic Regulatory Solutions Full timeRole- Regulatory Affairs ManagerLocation West Midlands and Remote workingSalary - On ApplicationManagement, review and submission of all post-approval applications required to support the portfolio – including, but not limited to, Type IA, IB & II Variations, BSVs, Renewals, MAH Transfers/COAs, Sunset Clause Notifications/exemptions and MA...
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Senior Regulatory Affairs Specialist
3 weeks ago
West Bowling, West Yorkshire, United Kingdom X4 Life Sciences Full timeA long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business. Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap. They are looking for an individual that is hard working and self-motivated to assist with all things...
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Senior Regulatory Affairs Associate
6 days ago
West Yorkshire, United Kingdom Michael Page (UK) Full timeAbout Our Client This organisation is a leader in the Pharmaceutical industry with a substantial presence. Employing over 1,000 dedicated professionals, the company is known for its commitment to research and development, producing high-quality pharmaceutical products that enhance and save lives. Job Description Assist in Regulatory activities including...
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Senior Regulatory Affairs Specialist
2 weeks ago
West Bowling, United Kingdom X4 Life Sciences Full timeA long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business.Is this your next job Read the full description below to find out, and do not hesitate to make an application.They are looking for an individual that is hard working and self-motivated to assist with...
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Senior Regulatory Affairs Specialist
2 weeks ago
West Bowling, United Kingdom X4 Life Sciences Full timeA long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business.Is your CV ready If so, and you are confident this is the role for you, make sure to apply asap.They are looking for an individual that is hard working and self-motivated to assist with all things...
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Senior Regulatory Affairs Specialist
1 week ago
South Yorkshire, United Kingdom Austin Vita Full timeThe Senior Regulatory Affairs Specialist is responsible for ensuring medical device regulatory compliance with national and international legislation for projects, product and new market clearance. You will manage specific regulatory objectives to meet the company’s Strategic Plan and Department Operational Objectives. Assisting and sometimes deputising...
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Regulatory Affairs Officer
2 weeks ago
West Yorkshire, United Kingdom WALKER COLE INTERNATIONAL LTD Full timeWalker Cole International is searching for a Regulatory Affairs Officer to join a large pharmaceutical company based in West Yorkshire. As a Regulatory Affairs Officer, you will be responsible for the on-going maintenance of the organisations prescriptionlicensed medicine portfolio and support new product development activities. Your key responsibilities...
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Senior Regulatory Affairs Specialist
1 week ago
South Yorkshire, United Kingdom Austin Vita Full timeThe Senior Regulatory Affairs Specialist is responsible for ensuring medical device regulatory compliance with national and international legislation for projects, product and new market clearance. You will manage specific regulatory objectives to meet the company’s Strategic Plan and Department Operational Objectives. Assisting and sometimes deputising...
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Regulatory Specialist and Senior Specialist
2 weeks ago
East Grinstead, West Sussex, United Kingdom Hunter Selection Full time €55,000Senior Regulatory Affairs Specialist Remote / Hybrid Remote working (Occasional travel to site depending on location) 25 days holidays plus bank holidays Pension Scheme Healthcare cash plan Sick Pay Life Assurance An award-winning medical manufacturer in South West Wales is currently looking to strengthen its Regulatory team with the key...
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Regulatory Specialist and Senior Specialist
2 weeks ago
East Grinstead, West Sussex, United Kingdom Hunter Selection Full time €55,000Senior Regulatory Affairs Specialist Remote / Hybrid Remote working (Occasional travel to site depending on location) 25 days holidays plus bank holidays Pension Scheme Healthcare cash plan Sick Pay Life Assurance An award-winning medical manufacturer in South West Wales is currently looking to strengthen its Regulatory team with the key...
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Director of Regulatory Affairs
2 months ago
Solihull, West Midlands, United Kingdom Novera Search Full timeWe are currently partnered with an exciting, commercial-stage biotech looking to recruit a Director, Regulatory Affairs, EU to join their growing team in Ireland. The company is looking to expand their commercial regulatory team, hiring someone to lead the development and execution of regulatory strategies across Europe. You will need to have a good...
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Regulatory Affairs Manager
2 weeks ago
West Midlands, West Midlands, West Midlands, West Midlands, UK, United Kingdom Mosaic Regulatory Solutions Full timeRole- Regulatory Affairs Manager Location West Midlands and Remote working Salary - On Application Management, review and submission of all post-approval applications required to support the portfolio – including, but not limited to, Type IA, IB & II Variations, BSVs, Renewals, MAH Transfers/COAs, Sunset Clause Notifications/exemptions and MA...
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Senior Regulatory Affairs Specialist
5 days ago
West Yorkshire, United Kingdom X4 Life Sciences Full timeA long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business. They are looking for an individual that is hard working and self-motivated to assist with all things regulatory. Responsibilities will include: Provide technical support to the business, suppliers and...
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Senior Regulatory Affairs Specialist
6 days ago
West Yorkshire, United Kingdom X4 Life Sciences Full timeA long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business.They are looking for an individual that is hard working and self-motivated to assist with all things regulatory. Responsibilities will include:Provide technical support to the business, suppliers and...
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Senior Regulatory Affairs Specialist
3 weeks ago
West Yorkshire, United Kingdom X4 Life Sciences Full timeA long term Medical Device client of ours based in West Yorkshire, are looking to add a Regulatory Specialist to their team to support their growing business. They are looking for an individual that is hard working and self-motivated to assist with all things regulatory. Responsibilities will include: Provide technical support to the business, suppliers and...