Reference Number: JO-2006-450675
Regulatory Affairs Manager
Job Type: Permanent
Role: Regulatory Affairs Manager
Salary: highly competitive + benefits
Full time, permanent
Regulatory Professionals are collaborating with an American multinational medical devices and health care company. Our client is looking for a Regulatory Affairs professional with extensive MDR transition and people management experience. In this role you will be supporting the significant manufacturing capacity expansion underway at our clients Oxford site plus other Operational and R&D projects.
Other duties will include:
In collaboration with the Regulatory leadership, develop and implement regulatory strategies that appropriately assess regulatory impact and ensure earliest possible introduction of prod-uct(s) or post market change management activities into global markets.
Coordinate preparation of well organized, complete, and scientifically sound regulatory sub-missions.
Interface directly with various regulatory agencies, as required, to facilitate the review and ap-proval of regulatory applications and to address queries.
Exercise judgement within generally defined practices and departmental standard operating procedures.
Accountable for budgets, schedules, and ensuring compliance to divisional and corporate poli-cies as required.
Develop and maintain strong and effective relations with internal/external personnel.
Responsible for developing team talent.
Right to work in the UK
Extensive experience/knowledge on MDR
Educated to degree level or equivalent preferably in a scientific discipline e.g. Chemistry, life Sciences, Biology.
Experienced in regulatory submissions for in vitro diagnostic devices and/or medical devices.
Experience of working within the requirements of ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
If you would like to apply for this position, please contact Amani via firstname.lastname@example.org. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*