The Regulatory Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team. This position works closely with the RA Leadership Team.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.
SUMMARY
The Regulatory Affairs Specialist I is responsible for implementation of regulatory strategies including domestic and international submissions and other support of product project team.
This position works closely with the RA Leadership Team.
ESSENTIAL DUTIES AND RESPONSIBILITIES including but not limited to the following.
Provide 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
Provides technical collaborate with FDA and international reviewers, responds to questions, 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.
QUALIFICATIONS:
Knowledge of the U.S. and European medical device regulations preferred
Must have excellent written and verbal communication skills
Must be self-motivated by working independently and having the ability to take ownership of their responsibilities
Prioritize and handle several projects concurrently
Must have technical writing skills and be proficient at compiling successful submissions
Provide leadership and mentoring skills to less experienced regulatory
Maintain confidentiality in taking care of regulatory and clinical documentation.
EDUCATION and/or EXPERIENCE:
BS in a scientific field with 1+ years employment in the areas of medical device product registration, compliance or quality systems.
Combination of education and experience determined to be equivalent.
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.
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Primary Work LocationUSA GA - Covington BMDAdditional LocationsWork Shift