Job Description Summary

　　As Regulatory Affairs Specialist II i, you will be responsible for the implementation of strategies including domestic and international submissions and other product project team supports..

　　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 a maker 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 the 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

　　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  https://bd.com/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.