Current jobs related to Regulatory Affairs and Clinical Manager - Mountain Ash - Life Science Talent
-
Regulatory Affairs Manager, Medical Devices
3 months ago
Mountain Ash, United Kingdom Life Science Talent Full timeReporting to the Clinical DirectorOur client is a leading designer and global provider of innovative medical devices who proudly support clinicians to enhance their professional development and patient care. We are now recruiting for the position of Regulatory Affairs and Manager who will be responsible for the leadership and support of the Regulatory...
-
Regulatory Affairs Manager, Medical Devices
2 months ago
Mountain Ash, United Kingdom Life Science Talent Full timeReporting to the Clinical DirectorOur client is a leading designer and global provider of innovative medical devices who proudly support clinicians to enhance their professional development and patient care. We are now recruiting for the position of Regulatory Affairs and Manager who will be responsible for the leadership and support of the Regulatory...
-
Regulatory Affairs Leader, Medical Devices
4 weeks ago
Mountain Ash, United Kingdom Life Science Talent Full timeReporting to the Clinical Director Our client is a leading designer and global provider of innovative medical devices who proudly support clinicians to enhance their professional development and patient care. We are now recruiting for the position of Regulatory Affairs and Manager who will be responsible for the leadership and support of the Regulatory...
-
Regulatory Affairs Leader, Medical Devices
1 month ago
Mountain Ash, United Kingdom Life Science Talent Full timeReporting to the Clinical DirectorOur client is a leading designer and global provider of innovative medical devices who proudly support clinicians to enhance their professional development and patient care. We are now recruiting for the position of Regulatory Affairs and Manager who will be responsible for the leadership and support of the Regulatory...
-
Regulatory Affairs Leader, Medical Devices
1 month ago
Mountain Ash, United Kingdom Life Science Talent Full timeReporting to the Clinical DirectorOur client is a leading designer and global provider of innovative medical devices who proudly support clinicians to enhance their professional development and patient care. We are now recruiting for the position of Regulatory Affairs and Manager who will be responsible for the leadership and support of the Regulatory...
-
Regulatory Affairs Manager, Medical Devices
3 months ago
Mountain Ash, Wales, Rhondda Cynon Taff, United Kingdom Life Science Talent Full timeReporting to the Clinical DirectorOur client is a leading designer and global provider of innovative medical devices who proudly support clinicians to enhance their professional development and patient care. We are now recruiting for the position of Regulatory Affairs and Manager who will be responsible for the leadership and support of the Regulatory...
-
Regulatory Affairs Leader, Medical Devices
4 weeks ago
Mountain Ash, Rhondda Cynon Taf, United Kingdom Life Science Talent Full time €62,000 - €72,000Reporting to the Clinical Director Our client is a leading designer and global provider of innovative medical devices who proudly support clinicians to enhance their professional development and patient care. We are now recruiting for the position of Regulatory Affairs and Manager who will be responsible for the leadership and support of the Regulatory...
-
Regulatory Affairs Leader, Medical Devices
1 month ago
Mountain Ash, Rhondda Cynon Taf, United Kingdom Life Science Talent Full time €62,000 - €72,000Reporting to the Clinical Director Our client is a leading designer and global provider of innovative medical devices who proudly support clinicians to enhance their professional development and patient care. We are now recruiting for the position of Regulatory Affairs and Manager who will be responsible for the leadership and support of the Regulatory...
-
Development Management Team Leader
4 weeks ago
Mountain Ash, Rhondda Cynon Taf, United Kingdom Life Science Talent Full time €62,000 - €72,000Our client is a leading designer and global provider of innovative medical devices who proudly support clinicians to enhance their professional development and patient care. We are now recruiting for the position of Regulatory Affairs and Manager who will be responsible for the leadership and support of the Regulatory department personnel, overseeing all...
-
Development Management Team Leader
1 month ago
Mountain Ash, Rhondda Cynon Taf, United Kingdom Life Science Talent Full time €62,000 - €72,000Our client is a leading designer and global provider of innovative medical devices who proudly support clinicians to enhance their professional development and patient care. We are now recruiting for the position of Regulatory Affairs and Manager who will be responsible for the leadership and support of the Regulatory department personnel, overseeing all...
-
Continuing Health Care Support Nurse
4 weeks ago
Mountain Ash, United Kingdom Cwm Taf Morgannwg University Health Board Full timeAbout the RoleWe are seeking a highly skilled and experienced Continuing Health Care Support Nurse to join our team at Cwm Taf Morgannwg University Health Board. As a key member of our healthcare team, you will play a vital role in ensuring that individuals receive high-quality care and support in their own homes.Key ResponsibilitiesCollaborate with District...
-
Rail Safety Manager
3 days ago
Mountain Ash, United Kingdom Protech Rail & Civil Engineering Full timeJob Title: Health, Safety & Compliance ManagerProtech Rail Engineering is seeking a highly skilled Health, Safety & Compliance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the health, safety, and well-being of our employees, contractors, and the general public.Key Responsibilities:Develop, implement, and...
-
Rail Safety Manager
3 days ago
Mountain Ash, United Kingdom Protech Rail & Civil Engineering Full timeJob Title: Health, Safety & Compliance ManagerProtech Rail Engineering is seeking a highly skilled Health, Safety & Compliance Manager to join our team. As a key member of our organization, you will be responsible for ensuring the health, safety, and well-being of our employees, contractors, and the general public.Key Responsibilities:Develop, implement, and...
-
Claims Management Specialist
1 month ago
Mountain Ash, United Kingdom Cwm Taf Morgannwg University Health Board Full timePosition Overview The individual in this role will oversee their assigned cases and assist the Legal Services Manager in the organization and delivery of safe, high-quality healthcare services to patients across various sectors of Cwm Taf Morgannwg University Health Board, including independent contractor services. This position focuses on the...
-
Clinical Deputy Manager/Clinical Lead
7 days ago
Five Ash Down, East Sussex, United Kingdom Barchester Healthcare Full timePeripatetic Deputy General Manager (Clinical) RoleAbout the Role:This is an exciting opportunity to join Barchester Healthcare as a Peripatetic Deputy General Manager (Clinical). As a key member of our leadership team, you will be responsible for managing and developing teams in various care homes across the region.Key Responsibilities:Travel across the...
-
Clinical Deputy Manager/Clinical Lead
7 days ago
Five Ash Down, East Sussex, United Kingdom Barchester Healthcare Full timePeripatetic Deputy General Manager (Clinical) RoleAbout the Role:This is an exciting opportunity to join Barchester Healthcare as a Peripatetic Deputy General Manager (Clinical). As a key member of our leadership team, you will be responsible for managing and developing teams in various care homes across the region.Key Responsibilities:Travel across the...
-
Claims Investigation Officer
4 weeks ago
Mountain Ash, United Kingdom Cwm Taf Morgannwg University Health Board Full timeJob SummaryThe postholder will be responsible for managing their cases and supporting the Legal Services Manager in the provision and planning of safe, high-quality healthcare to patients across all areas of Cwm Taf Morgannwg University Health Board, inclusive of independent contractor services. This will involve the case management of Claims, Inquests, and...
-
Senior Quality Assurance Engineer
1 week ago
Mountain Ash, United Kingdom Flexicare Limited Full timeJob Title: Senior Engineer Advanced QualityFlexicare Limited is seeking a highly skilled Senior Engineer Advanced Quality to join our growing global Quality Team. As a key member of our team, you will provide leadership and direction in quality assurance, control, and preventative activities within operations and other business functions.Key...
-
Senior Quality Assurance Engineer
1 week ago
Mountain Ash, United Kingdom Flexicare Limited Full timeJob Title: Senior Engineer Advanced QualityFlexicare Limited is seeking a highly skilled Senior Engineer Advanced Quality to join our growing global Quality Team. As a key member of our team, you will provide leadership and direction in quality assurance, control, and preventative activities within operations and other business functions.Key...
-
Clinical Deputy Manager
4 days ago
Five Ash Down, East Sussex, United Kingdom Barchester Healthcare Full timePeripatetic Deputy Manager & Clinical LeadThis role will be based initially at a care home in East Sussex. You will then be required to support at our other locations from time to time within the region, including Uckfield, Shoreham on sea, Henfield and Wadhurst. Mileage will be paid from your base home.As a Peripatetic Deputy General Manager (Clinical) at...
Regulatory Affairs and Clinical Manager
3 months ago
Reporting to the Clinical Director
Our client is a leading designer and global provider of innovative medical devices who proudly support clinicians to enhance their professional development and patient care. We are now recruiting for the position of Regulatory Affairs and Clinical (RAC) Manager who will be responsible for the leadership and support of the Regulatory and Clinical department personnel, overseeing all activities relating to registration requirements, regulatory strategy and new product development or product line extension indications and working closely with the international territory managers & global teams to facilitate & maintain device registrations.
In addition, the RAC Manager will be responsible for overseeing any Clinical Affairs activity, including clinical evaluation, PMCF and clinical investigation activities as well as supporting post market surveillance actions.
Responsibilities
- To lead and contribute towards a variety of different projects, ensuring compliance of UK, EU and US regulatory requirements across the company structure, including processes, documentation, systems and product files.
- Keep up to date with market trends and new developments utilising information for business improvement.
- Understand and develop long term business vision.
- Careful delegation of tasks whilst maintaining responsibility for final result.
- Planning of registration activity to achieve accurate and timely results.
- Responsible for coordination & preparation of regulatory submissions and strategies.
- Develop & maintain regulatory knowledge of European, FDA and country specific regulations.
- Managing a team that consists of several UK & overseas regulatory staff.
- Identify compliance issues & conduct or direct required investigation.
- Lead Company transition to EU-MDR requirements.
- Lead Clinical activities such clinical evaluation, PMCF and clinical investigations with a particular focus on EU-MDR requirements
- Serve as a point of contact for employees to communicate with management, seek clarification on issues or dilemmas, or report irregularities.
- Discuss emerging compliance issues with management and/or employees.
- Review or modify policies or operating guidelines to comply with changes to standards or regulations.
- Provide assistance in support of internal and external audits and serve as process owner for regulatory and clinical processes
- Keep informed regarding pending industry changes, trends, and best practices and assess the potential impact of these changes on organisational processes.
Skills & Experience
Proven experience as a Regulatory Affairs professional with particular knowledge of regulatory requirements for medical devices including registration, manufacturing and post-market controls (including ISO 13485 and ISO 14971)
Effective people-management skills – managing and overseeing the professional development of team members.
ISO 9001
ISO 13485
ISO 14155
ISO 14971
FDA requirements for 510(k)
93/42/EEC MDD & 2017/745 MDR
Proven experience of managing a team
Prior experience of CER support
SFDA, KFDA, CFDA, CDSCO (desirable)
- Strong collaborative skills – a confident and clear communicator able to inform and influence diverse stakeholder groups.
- Worked internationally, liaised effectively across various cultures and time-zones.
- An appetite to work in a fast-paced, entrepreneurial environment.
- Worked effectively in project teams, with a commitment to play a vital role in meeting team-based deliverables and timelines.
Our client is offering an attractive salary and benefits package along with excellent ongoing career development and training and the opportunity to work with leading specialists to develop products that advance the delivery of their patient’s care.
Salary - £62 -£72K (in circa of)
Benefits - Pension (EE5%, ER5%), Car Allowance, Private Medical Insurance, Health Cash Plan, Life Assurance (2 x salary), Income Protection (50% salary), Monthly benefit fund to use towards other benefits or put into pension pot
