BD (Becton, Dickinson and Company) Jobs

Mobile bd.jobs Logo

Job Information

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

Job Description Summary

Job Description

The Regulatory Affairs Specialist II is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team. This position will support EU MDR project deliverables.

**“This position is a temporary assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy. This position will support BD & BARD integration efforts and is anticipated to last approximately through September 2023**.

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.

  • Provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, timeline development, change control and preparing submission related documents)

  • Prepare and audit 510(k)s, IDEs, PMA and/or international submissions as required

  • Provide technical interface with FDA and international reviewers and respond to questions

  • Provide the appropriate information to support international product registrations

  • Provide timely review and approval of product labeling and marketing claims for regulatory compliance

  • Provide support required for CE marking activities, including preparation and maintenance of product technical files and clinical evaluations

  • May supervise and direct Project Team personnel; may provide direction to assistant personnel

QUALIFICATIONS:

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

  • Must have excellent written and verbal communication skills

  • Must be a team player

  • 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

  • Must be able to meet goals on time

  • Must have knowledge of the U.S.A. Federal Regulations and MDD/MDR for medical devices

  • Must have knowledge with the requirements for medical device registration/licensing in the EU. Experience with Japan, Canada, Australia, Latin America and Asia/Pacific is preferred.

  • Must live within 50 miles of Covington, GA.

EDUCATION and/or EXPERIENCE :

  • BS in a scientific discipline with 3-5 years of medical device experience in the areas of product registration, compliance or quality systems; or

  • Combination of education and experience determined to be equivalent (pharma/medical device)

  • Regulatory Affairs Certification (RAC) desired

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, or any other protected status.

DirectEmployers