BD (Becton, Dickinson and Company) Regulatory Affairs Specialist II in Covington, Georgia
Job Description Summary
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
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
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.