**Job Description Summary**
Regulatory Affairs Specialist I, Hybrid - in office 3 days (Covington, GA)
Urology and Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting. The Regulatory Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.
**Job Description**
**Regulatory Affairs Specialist I – hybrid – Covington, Georgia**
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 a **maker of possible** with us.
Urology and Critical Care (UCC) is an established and trusted partner in urinary healthcare, developing complete solutions which optimize the urine drainage process in the Acute Care Hospital setting. The Regulatory Affairs Specialist I are responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.
**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 collaborate with FDA and international reviewers and respond to questions
+ 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
**Education and Experience required:**
+ BS in a scientific field with 1+ years employment in the areas of medical device product registration, compliance or quality systems; or Combination of education and experience determined to be equivalent
+ Regulatory Affairs Certification (RAC) desired
+ Knowledge of the U.S. and European medical device regulations preferred
+ Maintain confidentiality in dealing with regulatory and clinical documentation
+ Excellent written and verbal communication skills
+ Self-motivated by working independently and having the ability to take ownership of their 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
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
**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. It's also a place where we help each other be great, we do what's 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. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit? om/careers
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.
