- In collaboration with the Regulatory leadership, develop and implement regulatory strategies that appropriately assess regulatory impact and ensure earliest possible introduction of product(s) or post market change management activities into global markets.
- Coordinate preparation of well organized, complete, and scientifically sound regulatory submissions.
- Interface directly with various regulatory agencies, as required, to facilitate the review and approval 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 policies as required.
- Develop and maintain strong and effective relations with internal/external personnel.
- Responsible for developing team talent.
- 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).
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Regulatory Affairs Manager - Witney, United Kingdom - Abbott
Description
Abbott Diabetes Care designs, develops and manufactures leading-edge glucose monitoring systems and test strips for use in both home and hospital settings. Our product portfolio includes Freestyle Libre, a recently launched system that is revolutionising how people with diabetes around the world monitor their glucose levels. We are passionate about doing work that improves the quality of people's lives.
We currently have an opportunity for a Regulatory Affairs Manager to join our team, based in Oxfordshire, supporting the significant manufacturing capacity expansion underway at the Witney site plus other Operational and R&D projects.
Main Responsibilities as Regulatory Affairs Manager:
The Regulatory Affairs Manager applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs.
Qualifications and Required Experience:
As you'd expect from an innovative global healthcare company, we offer an excellent starting salary, and a competitive range of benefits including a defined contribution pension scheme, share ownership scheme, private healthcare, life assurance, and a flexible benefits scheme.
