Regulatory Manager

Benefits Package:
£55,000 - £60,000 Genuine progression opportunities available Extremely stable company Further benefits
A world class medical device supplier with a very lucrative product range are rapidly expanding the organisation and as a result of this they're looking for a Regulatory Manager to join their team. Significant investment has enabled the company to acquire new businesses and grow the company brand worldwide, The company's product range is established throughout the UK Asia, America, Mexico, Europe and more with plans to branch out further next year, this makes it a great time to join this lucrative organisation and manage a Regulatory team worldwide.
Role & Responsibilities:
Responsible for the leadership and support of the Regulatory department personnel, overseeing all activities relating to registration requirements and 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 all global 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.
Knowledge, 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
FDA / 93/42/EEC MDD & 2017/745 MDR
Proven experience of managing a team
Ability to liaise across teams globally, manage communication difficulties, compliance as well as NPD.
If you are interested in this role or looking for something similar please contact David Biggs at #####
or call for a confidential discussion on 02920894907
Hunter Selection is a nationwide provider of recruitment services in ENGINEERING, MANUFACTURING, SERVICE & TECHNOLOGY. Find out more about us and search all our current vacancies at hunterselection.co.uk
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