Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
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Job Type:
Full-Time -
Job Level:
Entry to Senior -
Travel:
Varies -
Salary:
Competitive -
Responsibilities
Job Description Summary
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 creativity 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 ground-breaking 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 are 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,.
**This position does not offer relocation assistance**
ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.
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
May provide direction of other personnel to accomplish duties
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
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 provide leadership and mentoring skills to less expert regulatory personnel
Must be able to 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; or
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 outstanding, 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 encourage people with the creativity and strive 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 happiness 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
#LI-PRO
Primary Work Location
USA GA - Covington BMDAdditional Locations
Work Shift
Success Profile
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Analytical
- Collaborative
- Communicator
- Persuasive
- Problem-solver
- Skilled presenter
Advancing the world of health™
BD is one of the largest global medical technology companies in the world and is advancing the world of health™ by improving medical discovery, diagnostics and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.