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Specialist II, Regulatory Affairs - Covington, United States - BD
Description
Job Description Summary
As Regulatory Affairs Specialist II, you will be responsible for the implementation of strategies including domestic and international submissions and other product project team supports.
This is a hybrid position where the candidate is required to be in the office a minimum of 3 days a week.
Office location is Covington, Georgia.Job Description
We are
the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health is our Purpose, and it's no small feat.
It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become amaker of possible
with us.
Key responsibilities will include:
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 collaboration with FDA and international reviewers and respond to questions
Provide timely review and approval of product labeling and marketing claims for regulatory compliance
Prepare and update STED technical files for CE marking activities and notified body interaction
May direct Project Team associates
About you:
To be successful in this role, you require:
Must have knowledge of U.S. and European medical device regulations
Must have excellent written and verbal communication skills
Must be self-motivated, work independently and have the ability to take ownership of responsibilities
Must be able to prioritize and handle several projects concurrently
Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience
Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
Education and/or Experience
:
BS in a Scientific field with 3-5 years of validated experience in the areas of product registration, compliance or quality systems; or a combination of equivalent education and experience
Regulatory Affairs Certification (RAC) desired
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