Job Description Summary

As Regulatory Affairs Specialist, you will be working in the BD Biosciences Unit on IVD devices with a focus on meeting sustaining IVDR requirements with guidance from the Regulatory Affairs Manager. This position requires an understanding of the current IVDR regulatory framework and processes to maintain CE IVD dossiers and sustain registered devices. Additionally, the position will include regulatory assessments for product changes, internal procedures updates, registration file support, and other related activities (e.g., UKCA transition). Associates will be expected to be onsite Monday through Thursday in our Milpitas, CA location.

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. 

The Regulatory Affairs Specialist will be working in the BD Biosciences Unit on IVD devices with a focus on meeting sustaining IVDR requirements with guidance from the Regulatory Affairs Manager. This position requires an understanding of the current IVDR regulatory framework and processes to maintain CE IVD dossiers and sustain registered devices. Additionally, the position will include regulatory assessments for product changes, internal procedures updates, registration file support, and other related activities (e.g., UKCA transition).

Primary Responsibilities:

• Work collaboratively with project teams to conduct updates to regulatory Technical Documentation

• Report on status of files, including identification and remediation of gaps for existing technical documentation in accordance with the requirements of IVDR (EU) 2017/746

• Conduct regulatory assessments for product and process changes

• Develop and update internal procedures and processes and files to fulfill UKCA regulations

• Provide support for CE marking activities including preparation and submission of product technical files, product labeling reviews, and support to international registrations and product release to market activities

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About You:

• B.S. degree in health science or life science field (biomedical engineering, engineering, computer science, biology, medical technology, etc.) RAC Certification a plus

• 1-2 years of experience in medical devices required (must have experience in one of the following areas; Regulatory Affairs, Quality or R&D

• Knowledge and experience with regulatory requirements for medical devices (CE mark technical files and design dossiers)

• Flow cytometer experience a plus

• Strong attention to detail and able to work on multiple tasks with limited supervision

• Excellent verbal and written communications skills, analytical thinking and technical writing skills

• Excellent organization and prioritization skills, and the ability especially ability to facilitate and document work

• Ability to identify areas of concern in complex projects and handle changes.

• Proven global perspective, customer focus, cross-functional collaboration and teamwork skills

• Digital literacy (Microsoft Word / Excel / PowerPoint)

• Knowledge of in vitro diagnostic device regulatory requirements

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.

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. 

Required Skills

Optional Skills

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Primary Work Location

USA CA - Milpitas 135

Additional Locations

Work Shift

NA (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 or hourly rate 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 or hourly rate offered to a successful candidate is based on experience, education, skills, and any step rate pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles.

Salary Range Information

$73,300.00 - $121,000.00 USD Annual