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REGULATROY AFFAIRS SPECIALIST

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Job Detail

  • Job ID 1005233
  • Career Level  Officer
  • Experience  2 Years
  • Industry  Management
  • Qualifications  Degree Bachelor

Job Description

Perform impact regulatory assessments for new product introductions for the responsible countries and assist in the development of registration plans.

Provides impact regulatory assessment arising from changes in product, manufacturing processes, labelling affecting IVD products in the distributed countries under responsibility, including communication to legal manufacturer Regulatory and project teams for impact assessment.

Provides visibility of ongoing product registrations and its status to through developed tracking processes monthly.

Follows up with regulatory authorities and Distributors on registration submissions until registered.

Updates the Regulatory Database (Velocity) with all product registration updates that assures status of currency.

To apply

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Required skills

2 years of experience as a regulatory expert within Medical devices or Diagnostics is Essential Able to compile dossiers adapted to meet country regulatory requirements. Bachelor’s degree (or higher) in a Healthcare or Life sciences’ discipline, Experience with Multiple countries, ideally Tanzania is essential Must have deep knowledge and successful track record with dealing with regulations / regulators in t

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