Job Description Summary

BD is seeking a Regulatory Affairs Specialist II to join our team in Covington, GA. This is a hybrid role with 4 days working at our office. The Regulatory Affairs Specialist II is responsible for implementing strategies, including domestic and international submissions, and providing support to product project teams throughout the product life cycle.

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 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.

This is a hybrid role with 4 days working at our Covington, GA office

Summary

The Regulatory Affairs Specialist II is responsible for implementation of strategies including domestic and international submissions and other support of product project team.

Requirements

• 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, PMAs, 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

• Update STED technical files for CE marking activities and notified body interaction to accomplish EU/MDR product

• May direct Project Team personnel; may provide direction to assistant personnel

Education

Bachelor's degree 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 education and experience determined to be equivalent.

Certifications

• Regulatory Affairs Certification (RAC) desired

Compensation

Competitive compensation package offered, including comprehensive benefits and opportunities for professional growth.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

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 Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.

Required Skills

Optional Skills

.

Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift