- 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
- 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
- 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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Specialist II, Regulatory Affairs - Covington, United States - BD (Becton, Dickinson and Company)
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 its no small feat.
It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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 youll be supported to learn, grow and become your best self. Become amaker of possible
with us.
Key responsibilities will include:
About you:
To be successful in this role, you require:
EDUCATION and/or EXPERIENCE :
For certain roles at BD, employment is contingent upon the Companys receipt of sufficient proof that you are fully vaccinated against COVID-19.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work.
Its also a place where we help each other be great, we do whats right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do.
To learn more about BD visit?
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.
PDN
Primary Work Location
USA 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.
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