Regulatory Affairs Leader, Medical Devices
3 weeks 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 Manager who will be responsible for the leadership and support of the Regulatory 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 RA 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
-
Regulatory Affairs Leader, Medical Devices
2 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...
-
Mountain Ash, United Kingdom Life Science Talent Full timePosition OverviewReporting directly to the Clinical Director, this role is integral to a prominent organization recognized for its innovative medical device solutions. The successful candidate will oversee the Regulatory Affairs department, guiding personnel in all aspects of regulatory compliance, strategic planning, and the development of new products or...
-
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 Manager, 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
2 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
3 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 Manager, Medical Devices
2 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...
-
Development Management Team Leader
2 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
3 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...
-
Microbiology abd Regulatory Technician
3 weeks ago
Mountain Ash, United Kingdom Rocialle Healthcare Ltd Full timeJob Purpose: To work with the Quality and Regulatory Affairs Manager to ensure that all the regulatory requirements are met, as stipulated in the ISO 14644 and ISO 17141 series of standards. The Microbiology and Regulatory Technician will be required to support the regulatory department in other areas such as assisting in machine validation, environmental...
-
Community Healthcare Support Worker
3 months ago
Mountain Ash, United Kingdom Cwm Taf Morgannwg University Health Board Full time**Principal duties**: The post holder will be required to undertake a range of clinical and clerical activities as delegated by the Team Leader/Deputy Team Leader in the OOH District Nursing Service. These activities will be carried out in a variety of settings including the district nurses base, patients homes, clinic settings, GP surgeries, residential and...
-
Admin Assistant
4 months ago
Mountain Ash, United Kingdom Cwm Taf Morgannwg University Health Board Full timeOrganise own daily work processes Monitor and review data capture systems, ensuring that quality and accuracy of data capture and reporting is consistently high Undertake and assist in regular data accuracy checks and data cleansing Deal efficiently and effectively with correspondence and queries, often of a highly confidential nature from other agencies and...
-
Regional Manager
3 weeks ago
Mountain Ash, United Kingdom Compass Group UK & Ireland Full timeInstore Regional Manager - South Wales Remote with travel across sites in South Wales£48000 per annum As the Regional Manager, you will be responsible for overseeing all food services within the Instore cafes. You will liaise with multiple site-based clients, managing the relationship in each location, ensuring compliance and company policies are adhered...
-
Continuing Health Care Support Nurse
2 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...
-
Continuing Health Care Support Nurse
4 months ago
Mountain Ash, United Kingdom Cwm Taf Morgannwg University Health Board Full timeJob summary The post-holder will assist the Continuing Health Care Co-ordinator in coordinating and sustaining a continuing health care model and service to meet the needs of the adult population of Merthyr, Cynon, Rhondda and Taff Ely. Main duties of the job The post-holder will be responsible for ensuring that the service provided to...
-
Asset Support Engineer
3 months ago
Ash, United Kingdom Precision Hire Solution Full timeJob RequirementsDo you enjoy beingpart of team that provides highquality engineering for ourcustomers Do you enjoy beinga part of a successfulteam Join ourTeam! Industry Energy technology (IET)part of Baker Hughes Company operates across 120 countries andserves the entire energy valuechain and industrial sector. We holdan extensive portfolio of rotating...