BD (Becton, Dickinson and Company) Regulatory Affairs Specialist I in Covington, Georgia

Job Description Summary

Job Description

The position of Regulatory Affairs Specialist is responsible for the development and support of China FDA medical device registrations with International Business Center (IBC) contacts in China. The candidate requires a working knowledge of relevant Chinese medical device regulations and guidance documents.

Essential job functions:

  • Streamline the China registration process to gain clarity to registration requirements and improve registration timing

  • Prepares and supports China FDA first time, renewal, and change registration submissions as required and per applicable SOPs.

  • Collaborate with cross-functional teams to support in-process China registrations or projects

  • Performs special projects as needed.

Basic qualifications:

  • Ability to conduct business in Chinese (Mandarin) is a MUST

  • Must have knowledge of Chinese medical device regulations and standards

  • Must have experience working with international businesses or cultures

  • Must be able to maintain confidentiality in dealing with regulatory and clinical documentation

  • Must have excellent written and verbal communication skills

  • Must be able to utilize tools to create reports, metrics, etc.

  • Must be able to prioritize and handle several projects concurrently

  • Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities

  • Must be computer literate with strong Excel knowledge

  • Must be able to meet goals on time

Education/Experience

  • BS in a scientific/engineering discipline with 1-3 years employment in the areas of medical device product development, product regulatory registrations/submissions or quality systems or

  • Combination of education and experience determined to be equivalent

  • Regulatory Affairs Certification (RAC) desired

  • Ability to conduct business in Chinese (Mandarin) is a MUST

  • This position doesnot provide relocation assistance.

Primary Work LocationUSA GA - Covington BMD

Additional Locations

Work Shift

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