Becton, Dickinson and Company

Sr. Regulatory Specialist

Becton, Dickinson and Company • $80K — $110K *
Covington, GA 30016In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • Bachelor’s degree in a scientific discipline or regulated industry required
  • 5-7 years of experience in medical device regulatory affairs preferred
  • Experience with U.S. (510(k)), EU (Tech File/STED), and international submissions
  • Strong knowledge of medical device regulations including IEC 60601 standards
  • Proficient in technical writing for regulatory submissions

Responsibilities

  • Lead regulatory strategy for product project teams and manage lifecycle support
  • Prepare STED technical files for CE marking compliance and notified body interactions
  • Provide guidance for post-market activities including labeling updates
  • Support U.S., EU, and international submissions for new products and changes
  • Drive process improvements and mentor junior team members

Benefits

  • Flexibility to work remotely one day a week
  • Collaborative on-site working environment with a culture of creativity
  • Opportunities for professional development and mentorship
  • Ability to engage in multiple project types and initiatives
  • Work in a fast-paced, innovative healthcare industry
Full Job Description
Job Description

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 Home and Acute Care Hospital setting.  The Senior Regulatory Affairs Specialist is responsible for preparation of U.S and CE marking submissions/registration activities, along with supporting all other geographical region registrations. In addition, this position will work cross-functionally to develop regulatory strategy across the product lifecycle.

This role provides the flexibility to work on site 4 days weekly in Covington, and remotely Friday on a weekly basis.

To be successful in this role, you will work independently by applying your written and analytical skills to create technical documents, in some cases to cover design changes and change notifications for BD’s wide range of medical devices.   You will also leverage your communication skills to work effectively with internal customers and team members as well as external auditors.

Key responsibilities will include:

  • Lead regulatory strategy and lifecycle support for product project teams, including change controls, timelines, and submission document review
  • Prepare and maintain STED technical files to support CE marking and ensure compliance with EU MDR requirements, including notified body interactions
  • Provide regulatory guidance for post-market activities such as remediation actions and labeling updates
  • Lead and support U.S., EU, and international submissions, including NPD initiatives and change assessments
  • Drive process improvements, mentor team members, and support audits, regulatory inspections, and cross-functional initiatives (e.g., Kaizen events)

Minimum Requirements:

  • Bachelor’s degree required, preferably in a scientific discipline or regulated industry; ability to travel up to 15% as needed
  • Experience authoring and supporting U.S. (510(k)), EU (Tech File/STED), and international regulatory submissions
  • Proven ability to update and maintain STED files for CE marking and support notified body interactions under EU MDR
  • Strong knowledge of U.S. and European medical device regulations, including familiarity with IEC 60601 standards and post-market regulatory requirements
  • Demonstrated ability to manage multiple projects, maintain strict confidentiality, and provide regulatory strategy, labeling review, and post-market guidance

Preferred Requirements:

  • 4 - 7 years experience in medical device (to include some experience within medical device); experience in areas of product registration, new product development and product changes highly preferred

  • Regulatory Affairs Certification (RAC) preferred.

  • Must demonstrate ability to provide regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control assessments, timeline development, and reviewing submission related documents).

  • Must be able to work in fast paced and complex environment juggling various priorities.

  • Must be self-motivated by working independently and having the ability to take ownership of their responsibilities.

  • Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience.

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.

Primary Work LocationUSA GA - Covington BMD

Additional Locations

Work Shift

About Becton, Dickinson and Company

BD is a global technology company that provides diagnostics and technologies for frontliners. Through their solutions and services, they assist scientists in detecting diseases and advanced researchers' on developing diagnoses and therapeutics. BD was established in 1897 by Farleigh Dickinson and Maxwell Becton in East Rutherford, New Jersey.

Becton, Dickinson and Company Careers

Join the innovative world of Becton, Dickinson and Company (BD), a global medical technology company that is actively seeking driven, dedicated professionals to join our team. At BD, we are committed to advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. This commitment provides the foundation for a workplace where you can engage in meaningful work and where job opportunities abound.

Work You’ll Do

At BD, you will be part of a culture that values diversity, leadership, and innovation. Our team members are empowered to lead and inspire from day one. Join us and contribute to our mission of advancing the world of health through your professional skills and personal passion.

Transform Your Career

BD offers a unique position in the marketplace that combines industry expertise, leadership in medical innovation, and a collaborative culture to help you grow your career. Whether you are looking for an entry-level position or a more senior role, we provide the tools and support for your professional growth through comprehensive training and development programs.

Innovative Work Environment

Our team at BD is composed of more than 65,000 associates across the globe. These dedicated professionals work at the intersection of technology and healthcare, where they drive innovation and ensure that we stay ahead in a rapidly evolving industry. By joining BD, you will work alongside some of the brightest minds in the industry.

Internship and Employment Opportunities

Start your career with BD through our internship programs or dive straight into a full-time position. We offer a range of opportunities that allow you to explore different areas of our business and find a path that aligns with your career goals. Our hiring process is designed to be transparent and engaging, ensuring that all candidates—whether submitting a resume for an internship or a senior position—feel valued and informed.

Benefits and Culture

BD is proud to offer competitive benefits that support the health, well-being, and financial security of our employees and their families. From comprehensive health insurance to employee wellness programs and flexible working arrangements, we prioritize the well-being of our team members. Our inclusive culture encourages networking, continuous learning, and the sharing of ideas in a diverse and welcoming environment.

Join Our Team

Explore the job opportunities at BD and discover how your expertise can help shape the future of healthcare. Search open positions that match your skills and interests. We look for passionate, curious, creative, and solution-driven team players.

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Explore Careers at BD

Whether you're preparing for your first interview or looking to advance into a leadership role, BD offers career paths that foster continuous growth and innovation. Join us in our mission to improve medical outcomes and enhance patient care worldwide.

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At Becton, Dickinson and Company, we are more than just a company; we are a community that is dedicated to making a difference in the lives of people all around the world.
Learn more about Becton, Dickinson and Company
Size
75,000 employees
Market Cap
$72 billion
Industry
Healthcare
Net Income
$1.6 billion
Founded
1897
5 Year Trend
+9.3%
Revenue
$18.2 billion
NASDAQ
BDX
* Ladders Estimates

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