Becton, Dickinson and Company

Senior Manager Regulatory Affairs

Becton, Dickinson and Company • $120K — $145K *
Covington, GA 30016In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a scientific or technical discipline required; MS or PhD preferred.
  • 8-10 years of experience in Regulatory Affairs within the medical device sector, with 3-5 years in senior roles.
  • Expertise in preparing and submitting various regulatory applications like 510(k), PMA, and CE Mark.
  • Strong knowledge of FDA regulations, ISO 13485, and EU MDR.
  • Excellent written and verbal communication skills.
  • Proven ability to manage projects and multiple priorities effectively.
  • Regulatory Affairs Certification (RAC) is preferred.

Responsibilities

  • Develop and implement regulatory strategies for new product development and lifecycle management.
  • Prepare and submit regulatory documents to global health authorities.
  • Act as primary regulatory contact for projects, communicating directly with agencies during submissions.
  • Interpret complex regulations to ensure product compliance throughout development.
  • Lead and mentor junior regulatory professionals to foster compliance.
  • Participate in audits by providing regulatory expertise.
  • Assess regulatory impacts of product and manufacturing changes.
  • Collaborate with departments like R&D and Quality to achieve regulatory objectives.
  • Stay updated on changes in regulatory requirements and trends.

Benefits

  • On-site collaboration to foster creativity and innovation.
  • Minimum of 4 days in-office presence to maintain culture and operational smoothness.
  • Recognition of the importance of flexibility and work-life balance.
Full Job Description
Job Description

***Role is onsite in Covington, Georgia***

Job Responsibilities
  • Develop and implement comprehensive regulatory strategies for new product development, product
  • life cycle management, and post-market surveillance activities.
  • Prepare, review, and submit regulatory documents, including 510(k)s, Dossiers, Technical Files, and other international submissions to global health authorities.
  • Act as the primary regulatory contact for assigned projects, communicating directly with regulatory agencies during submissions, reviews, and inspections.
  • Interpret and apply complex regulations, guidance documents, and industry standards to ensure product compliance throughout the development and commercialization process.
  • Lead and mentor junior regulatory affairs professionals, fostering a culture of compliance and continuous improvement.
  • Participate in internal and external audits, providing regulatory expertise and support.
  • Assess the regulatory impact of product changes, manufacturing changes, and quality system changes.
  • Collaborate effectively with R&D, Quality, Clinical, Marketing, and other relevant departments to achieve regulatory objectives.
  • Monitor and disseminate information regarding new or changing regulatory requirements and industry trends relevant to the company's product portfolio.


Job Qualifications
  • Bachelor's degree in a scientific or technical discipline (e.g., Biomedical Engineering, Chemistry, Biology) required. Advanced degree (MS, PhD) preferred.
  • Minimum of 8-10 years of experience in Regulatory Affairs within the medical device industry, with at least 3-5 years in a leadership or senior role.
  • Demonstrated expertise in preparing and submitting various regulatory applications (e.g., 510(k), PMA, CE Mark, International registrations).
  • Strong knowledge of FDA regulations (21 CFR Parts 800s), ISO 13485, Medical Device Regulation (EU MDR), and other relevant international regulatory requirements.
  • Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to diverse audiences.
  • Proven ability to lead projects, manage multiple priorities, and work effectively in a fast-paced environment.
  • RAC (Regulatory Affairs Certification) preferred.
  • Proficiency in regulatory information management systems and tools.


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

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.

Stay Connected

Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. See what exciting and rewarding opportunities await at Becton, Dickinson and Company.

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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