Job Description Summary

Job Description

We are the makers of possible 

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Senior Regulatory Affairs Specialist (Multiple Positions), Becton Dickinson and Company, Milpitas, CA. Prepare regulatory documentation and submissions of In-Vitro Diagnostic Devices (IVD) worldwide. Apply deep understanding of global regulatory landscape to analyze and compile country-specific regulatory requirements. Ensure project plans are following relevant regulations and timelines. Review technical documentation to ensure necessary information and data are accurately included. Interpret regulatory rules associated with registration of products in international regions. Collaborate with cross-functional teams to prepare additional data required by regulatory agencies. Perform and communicate regulatory impact assessment. Develop and maintain regulatory approval metrics. Obtain regulatory certificates to facilitate international product distribution and sales.

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. Salary: $103,500.00 - $170,800.00/yr.

MINIMUM REQUIREMENTS:

Bachelor’s degree, or foreign equivalent degree, in Chemistry, Biology, Bioengineering or a related field, and three (3) years of related work experience.

Must have three (3) years of experience with/in:

Interpreting IVD regulatory requirements, including Good Laboratory Practices (GLP), Quality System Regulations (QSR), and European Quality System standards;Product registration/assessment for international regions such as APAC, EMEA or LATAM including countries such as China, Brazil, India, Philippines, South Korea;Working with internal and external teams to monitor and interpret new regulatory requirements;Device/diagnostic, biologic, or pharmaceutical industry in Regulatory Affairs;Participating in setting regulatory operation process, including the regulatory document management, submission tracking, reporting, data analysis, and dashboard or metrics development;Utilizing tools and/or technologies like SAP, Access, Agile, or Regulatory E-Systems; andAssisting in creating, implementing and revising departmental procedures.

Telecommuting is permitted up to 2 days a week.

To apply, mail resume to: Attn: Cheyenne Bryant, 5859 Farinon Drive, San Antonio, TX 78249 OR submit a resume to https://bdx.wd1.myworkdayjobs.com/en-US/EXTERNAL_CAREER_SITE_USA   R-495957 

#DNPBD

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.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place. 

To learn more about BD visit https://bd.com/careers

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

Primary Work LocationUSA CA - Milpitas 135

Additional Locations

Work ShiftNA (United States of America)

At BD, we are strongly committed to investing in our associates—their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture.  We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You.

Salary ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates’ progress, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary offered to a successful candidate is based on experience, education, skills, and actual work location. Salary ranges may vary for Field-based and Remote roles.

Salary Range Information

$90,000.00 - $148,400.00 USD Annual