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Regulatory Affairs Leader, Medical Devices
2 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 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
