Regulatory Project Manager

at  Abbott Laboratories

QUALIFICATIONS AND REQUIRED EXPERIENCE:

• 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).
  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

The Regulatory Affairs Project Manager applies advanced regulatory expertise to guide cross-functional partners and demonstrates strategic thinking and creativity in support of key business programs.

• 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.