Regulatory Affairs Manager

Abbott

Witney, United Kingdom
Competitive salary; not specified; excellent benef...
Not specified (assumed hybrid)
Eu regulatory strategy
Project management of regulatory projects
Notified body strategy
Abbott is seeking a Regulatory Affairs Manager for its Diabetes Care division in Witney, UK, to lead the development and implementation of regulatory strategies for their glucose monitoring products. The role involves collaboration with various internal and external stakeholders to ensure compliance with regulatory standards, particularly within the EU

Job Summary

  • Set the EU Regulatory Strategy that is well-defined and effective, setting out innovative solutions to Regulatory Approval.
  • Oversee the Project Management of regulatory projects, integrating with the US and OUS Regulatory organisation, the R&D organisation and other key functional groups.
  • Ensure that products designed, changed or purchased by ADC in Europe meet the quality and regulatory standards as required by regulatory, quality, Abbott Corporate and national requirements.

Matching Summary

Match Score: 85

Abbott is seeking a Regulatory Affairs Manager for its Diabetes Care division in Witney, UK, to lead the development and implementation of regulatory strategies for their glucose monitoring products. The role involves collaboration with various internal and external stakeholders to ensure compliance with regulatory standards, particularly within the EU.

Salary

Competitive Salary; Not specified; Excellent Benefits

Skills & Requirements

Must-have

  • EU Regulatory Strategy
  • Project Management of regulatory projects
  • Notified Body strategy
  • product registration planning
  • Quality System maintenance

Nice-to-have

  • innovative solutions for approval
  • strong communication skills
  • leadership on Notified Body strategy

Key Requirements

  • Bachelor’s degree in a Scientific discipline
  • Knowledge of ISO 13485
  • Knowledge of EMC
  • Knowledge of MDD (93/42/EEC)
  • Knowledge of IVDD (98/79/EC)
  • Knowledge of MDR 2017/745
  • Knowledge of IVDR 2017/756
  • Knowledge of FDA Quality Systems Regulations
  • Experience in medical or healthcare manufacturing
  • Excellent written and oral communication skills

Work Rights

Not specified

Tailored Resume

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