Becton, Dickinson and Company

Sr. Regulatory Affairs Specialist

Becton, Dickinson and Company • $100K — $130K *
San Jose, CA 95123In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in biological sciences, chemistry, or related field required.
  • Minimum 3 years' experience in regulatory affairs within the device, diagnostic, biologic, or pharmaceutical industry.
  • Experience in tech file preparation and approval is a plus.
  • Current knowledge of IVD regulatory requirements and international guidelines is essential.
  • Demonstrated ability to communicate effectively at all organizational levels.

Responsibilities

  • Develop and execute international regulatory strategies for IVD device registration.
  • Negotiate product submission priorities based on regional and country needs.
  • Generate and manage regulatory submission documents for compliance with global regulations.
  • Coordinate responses to regulatory agencies during the approval process.
  • Provide regulatory guidance in cross-functional product development teams.
  • Evaluate design and process changes for regulatory impact globally.
  • Review and approve labeling materials for compliance with regulations.

Benefits

  • Global presence with opportunities to impact healthcare on a large scale.
  • Engage in meaningful work at a top-tier medical technology company.
  • Opportunities for career growth within a large, influential organization.
  • Collaborative work environment supporting cross-functional teams.
  • Access to regulatory experts and ongoing professional development opportunities.
Full Job Description
Job Description
Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. Job responsibilities:Develop and execute international regulatory strategy for the successful registration of in vitro diagnostic (IVD) devices in markets outside of US and EU. Negotiate and establish product submission priorities that are aligned with IVDR priorities and region/country needs.Understands and interprets EU and international in vitro diagnostic (IVD) device regulatory requirements.Generate, coordinate, and manage regulatory submission documents for new products, renewals, or changes to existing products; ensure compliance with global regulations and guidelines. Coordinate responses to regulatory agencies as part of the submission and approval process.Represent RA in cross-functional product development teams to provide guidance on global regulatory strategies.Support change management by evaluating design, manufacturing and process changes for regulatory impact globally.Review Analytical and Clinical protocols to assure collection of appropriate data for regulatory submissions. Review/ Approve labels, labeling, and promotional materials for compliance with applicable regulations and policies. Develop and maintain procedures and/or work instructions for product registrations.Provide regulatory support during internal and external audits.Submit and maintain laser registrations for all instruments (IVD and RUO) when needed.Manage, monitor and track International product registration in Regulatory Information Management (RIM) database to ensure up to date information.Additional activities as needed to support RA goals.Minimum Qualifications:Education and Experience:Bachelor's degree required, strongly preferred in the biological sciences, chemistry or related science.Minimum 3 years' experience in the device/diagnostic, biologic and/or pharmaceutical industry, preferably in the area of regulatory affairs. Tech file preparation and approval experience a plus.Ideal candidate will have demonstrated ability to interpret new regulations, and understand and interpret in vitro diagnostic device (IVD) regulatory requirements.Current knowledge of in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP) and Quality System Regulations (QSR); and European quality system standards. Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization. Strong Project Management experience desirable, ability to prioritize, multi task, and organize work.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.

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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