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Development Management Team Leader
2 months ago
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.
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.
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.
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
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.
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.
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
