Becton, Dickinson and Company

Regulatory Affairs Specialist II

Becton, Dickinson and Company • $70K — $95K *
Covington, GA 30016In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
1 week ago
Job Overview by Ladders

Qualifications

  • Bachelor's degree required; preferably in a scientific field or engineering.
  • Minimum of 2 years of experience in Regulatory Affairs.
  • At least 1 year of experience with medical devices.
  • Knowledge of U.S. and European medical device regulations is essential.
  • Strong technical writing skills for successful regulatory submissions. Sorted ability to manage multiple projects.

Responsibilities

  • Support regulatory compliance throughout the product lifecycle.
  • Prepare and revise STED technical files for CE marking.
  • Develop regulatory strategies and manage change controls.
  • Assist with 510(k) submissions and change assessments.
  • Provide guidance on post-market activities and labeling.

Benefits

  • Flexibility to work onsite 4 days a week and remotely on Fridays.
  • Exposure to cross-functional teams and collaboration within a growing healthcare company.
  • Opportunity to engage with product lifecycle regulatory strategy.
  • Limited travel requirements, only up to 15%.
  • Culture of creativity and problem-solving in a supportive work environment.
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 Regulatory Affairs Specialist II 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 work cross-functionally to develop regulatory strategy across the product lifecycle.

This role provides the flexibility to work onsite 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's degree
  • Experience: 2+ years of experience in Regulatory Affairs
  • Medical Device Experience: 1 year of experience with medical devices
  • Core Competencies:
    • Ability to provide regulatory support through the product life cycle on product project teams (developing regulatory strategies, change control assessments, timeline development, and reviewing submission-related documents)
    • Ability to update STED technical files for CE marking activities and notified body interaction to maintain EU/MDR product registrations
    • Ability to maintain confidentiality when dealing with regulatory and clinical documentation
    • Ability to prioritize and handle several projects concurrently
    • Self-motivated with ability to work independently and take ownership of responsibilities
    • Knowledge of U.S. and European medical device regulations
    • Technical writing skills and proficiency at compiling successful submissions for the appropriate audience
  • Travel: Willingness to travel up to 15% (limited travel required)


Preferred Qualifications:
  • Bachelor of Science (BS) degree or higher; preferably in a Scientific Field, Engineering or Regulated Industry
  • Experience in product registration, compliance, or quality systems
  • Experience supporting 510(k) submissions
  • Experience supporting Tech File/STED File submissions
  • Regulatory Affairs Certification (RAC)


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.

Primary Work Location
USA 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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