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International Regulatory Affairs Specialist

Apply Now Job ID R-346131 Date posted 08/26/2019

Job Description Summary

This position is responsible for the development and implementation of product registration dossiers in support of international applications. The candidate will be expected to compose, review, and summarize product technical data that is required by regulatory agencies to demonstrate compliance with global regulations and standards. The candidate will be expected to interface and communicate effectively with international business colleagues and regulatory authorities. Knowledge of international regulatory affairs is preferred.

Job Description

Essential Job Functions

  • Ensures adequate documentation of BD PI’s compliance to worldwide regulations and standards.
  • Prepares and supports international submissions, product releases, Competent Authority notifications, marketing bid/tenders, and compliance with non-MDD/MDR directives in accordance with applicable SOPs.
  • Maintains regulatory affairs files.
  • Develops working relationships with key personnel at the business unit and representatives of international business centers as well as with ministries of health.
  • Participates in new product development teams, as required, to ensure the product is in compliance with all internal and external worldwide regulatory requirements. Reviews, documents, and supports a worldwide regulatory strategy in support of product development goals.

Basic Qualifications

  • Ability to plan and schedule multiple priorities in a concurrent fashion.
  • Ability to review, collate, and summarize scientific and technical data.
  • Ability to handle master documents, drawings, and specifications with a high degree of confidentiality.
  • Excellent problem solving and analytical skills.
  • Excellent written and oral communication skills.
  • Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy.
  • Complete work with minimal supervision and have the ability to work independently.
  • Knowledge of U.S. and/or international medical device regulations. 

Education and/or Experience

  • This position requires a Bachelor’s Degree in Law, Engineering, or one of the Life Sciences, or similar education.
  • The incumbent must have a minimum of 2 years employment in the areas of product registration, compliance, or quality systems; or
  • Combination of education and experience determined to be equivalent.
  • Experience in International Regulatory Affairs is preferred. 
  • Knowledge of a second language is preferred.

Primary Work Location

USA AZ - Tempe BPV Building 4

Additional Locations

Work Shift

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com