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Location

Witney, Oxfordshire | United Kingdom

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Job description

Regulatory Affairs Manager page is loaded

Regulatory Affairs Manager

Apply locations United Kingdom - Witney time type Full time posted on Posted 3 Days Ago job requisition id 31081141

JOB 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.

• 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.

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 base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Regulatory Operations

DIVISION:

ADC Diabetes Care

LOCATION:

United Kingdom > Witney : Range Road

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

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Regulatory Affairs Manager

locations United Kingdom - Witney time type Full time posted on Posted 20 Days Ago

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott  welcomes and encourages diversity in our workforce.

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