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Abbott Associate Manager Regulatory Affairs in Maidenhead, United Kingdom

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Abbott Diagnostics' broad range of innovative instruments and tests meets the needs of blood banks and laboratories of all specialties and sizes around the world. These products have helped transform the practice of medical diagnosis from an art to a science by greatly contributing to the modern diagnostics industry through our commitment to improving patient care.

Abbott Diagnostics (ADD) will be recruiting for an Associate Manager, Regulatory Affairs to support UK medical device product registrations.

Primary Objective of Position

· Serves as UK Authorized Representative (AR)

  • Responsible for UK product registrations

  • Identifies and reports new or changed regulations

  • Supports commercial organization with the required Regulatory Documentation

  • Supports product notification in EU countries

  • Acts as EU Regulatory backup

  • Responsible for vigilance reporting of medical device incidents (MDI) and Field Safety Corrective Actions (FSCA) and related correspondence to UK competent authorities

Major Accountabilities

Regulatory:

  • Serves as the main contact between the UK authorities and country affiliate

  • Performs product registrations, following the UK requirements, processes and timings

  • Reviews UK laws & regulations and elevates according to ADD elevation process

  • Supports locally developed Ad Promo material review and approval

  • Ensures performance evaluations requirements are met: guidance, notifications, submissions, follow-up with authorities and ethic committees

  • Supports customers and tender with RA documentation:

  • Generates and maintains RA documents

  • Coordinate its availability with QA organisation

  • Represents RA in the key country trade associations

  • Supports RA activities in the EU/EFTA countries, as needed

Vigilance:

  • Vigilance Reports to be reviewed and sent to UK Competent Authority for Abbott Diagnostics (ADD) and Abbott Molecular (AMD) products (In Vitro Diagnostics & Molecular Diagnostics) according to shared service agreements.

  • Requests from UK Competent Authority to be reviewed and responses to be collected, consolidated and submitted according expected time line

  • Follow-up reports to be sent to UK Competent Authority as requested or committed

  • Stay up to date on vigilance related regulation and guidelines applicable for UK, and EEA countries & Switzerland.

  • Support of EU Vigilance team as Vigilance contact back-up for EEA countries & Switzerland

Education

  • Solid scientific background (Degree in Medicine, Biology, Chemistry or Similar)

Background

  • Demonstrated experience in regulatory affairs in the diagnostic/medical device industry, ideally with experience of In Vitro Diagnostics

  • Experience to work in an international work environment or on international projects is required

  • Project management and negotiation skills

  • Ability to work independently

  • Proficient in English

  • Knowledge of PC- and internet based applications

Impact of position

  • Operates under Quality and Regulatory directives

  • Follows local regulations and European guidelines for vigilance

As you’d expect from a global healthcare company, we offer a fantastic range of benefits including competitive salaries, a superb defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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