Becton, Dickinson and Company

Sr. Regulatory Affairs Specialist

Becton, Dickinson and Company • $95K — $115K *
Covington, GA 30016In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor of Science (BS) degree in a scientific discipline, engineering, or regulated field required.
  • At least 4 years of Regulatory Affairs experience in the medical device industry.
  • Working knowledge of U.S. FDA regulations (21 CFR Part 820) and European Medical Device Regulation (EU MDR).
  • Experience with product registration and compliance activities for medical devices, including FDA 510(k).
  • Strong technical writing and analytical skills for creating regulatory documents.

Responsibilities

  • Support regulatory compliance throughout the product life cycle by creating strategies and timelines.
  • Prepare and revise technical files for CE marking and interact with notified bodies for EU regulation.
  • Guide and support post-market activities, including labeling and remedial actions.
  • Prepare and oversee 510(k) submissions and change assessments as needed.
  • Collaborate with cross-functional teams on product life cycles and regulatory deliverables.

Benefits

  • Flexible work arrangement with 4 days on-site in Covington and remote work on Fridays.
  • Limited travel requirement of up to 15%.
  • Opportunities for professional development and skill enhancement.
  • Emphasis on collaboration and innovation within the healthcare sector.
  • Engagement in a culture of excellence and support for work-life balance.
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 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 regions registrations. In addition, this position will help support RA management.

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

Key responsibilities will include:
  • Regulatory support through the product life cycle on product project teams (e.g., developing regulatory strategies, change control, timeline development, and reviewing submission related documents).
  • Prepare &/or revise STED technical files for CE marking activities and notified body interaction to support EU/MDR product maintenance, as required.
  • Provide support and guidance for post market activities including remedial actions, labeling.
  • Prepare and support 510(k) &/or change assessments, as required.
  • Limited travel required - 15%.


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.

Minimum Requirements:
  • Education: Bachelor of Science (BS) degree required, preferably in a scientific discipline, engineering, or other regulated field.
  • Experience:
    • Minimum 4 years of Regulatory Affairs experience within the medical device industry.
    • Experience supporting product registration, regulatory compliance, and quality system activities for medical devices.
  • Technical Knowledge: Working knowledge of U.S. FDA regulations, including 21 CFR Part 820, and European Medical Device Regulation (EU MDR).
  • Experience with:
    • U.S., EU, and international product registration activities.
    • Medical device quality systems and regulatory compliance.
    • Preparation and submission of FDA 510(k) premarket notifications.
    • Development and maintenance of technical documentation, including STED/Technical Files.
    • Interactions with regulatory authorities and/or EU Notified Bodies.
  • Core Competencies:
    • Demonstrated ability to support products throughout the product lifecycle, including product development, design changes, and post-market activities.
    • Experience developing regulatory strategies, conducting change assessments, and managing regulatory deliverables and timelines.
    • Strong technical writing skills with the ability to prepare clear, accurate, and compliant regulatory submissions.
    • Ability to maintain confidentiality when handling regulatory, clinical, and business-sensitive documentation.
    • Strong organizational and project management skills with the ability to prioritize multiple projects and meet deadlines.
    • Self-motivated with the ability to work independently, exercise sound judgment, and take ownership of responsibilities.
    • Effective written and verbal communication skills with demonstrated success working on cross-functional teams.
  • Work Arrangement: Ability to work on-site in Covington 4 days per week with remote work on Fridays
  • Travel: Willingness to travel up to 15% as needed


Preferred Qualifications:
  • Education: BS degree specifically in a Scientific Field (such as Biology, Chemistry, Biomedical Engineering)
  • Certification: Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS)
  • Product Knowledge: Familiarity with Class II medical devices, particularly in the urology or acute care hospital setting
  • Advanced Skills:
    • Experience leading regulatory activities on cross-functional product development teams.
    • Ability to influence project teams and communicate regulatory risks and mitigation strategies.
    • Strong analytical skills for evaluating technical data and determining regulatory impact.
    • Excellent communication skills for interactions with regulatory authorities, Notified Bodies, auditors, and cross-functional stakeholders.


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 Location
USA GA - Covington BMD

Additional Locations

Work Shift
US BD 1st Shift 8am-430pm (United States of America)

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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