Be part of something bigger at BD. Here, you’ll help us maintain our high standards from a regulatory perspective at all levels, with a keen focus on submissions. It requires acute attention to detail, excellent communication skills and a passion to keep learning and updating your knowledge, which we’ll help you do with regular learning opportunities. Here, you’ll use your in-depth knowledge of FDA, Canadian and ISO/MDD regulations and requirements surrounding medical devices to ultimately achieve a singular goal: advancing the world of health™. At BD, you can make a true difference of one.
Job Description SummaryBD Life Sciences – Staff Regulatory Affairs Specialist
Location – San Jose, CA
Staff Regulatory Affairs Specialist is responsible for creating and executing regulatory strategies and objectives in alignment with business needs. This includes the preparation of regulatory submissions required to market new or modified medical devices in the US, EU, and other geographies, and related regulatory affairs activities, such as development, execution and management of procedures and systems designed to ensure that the product development process, including clinical, non-clinical, and performance evaluation studies, addresses all regulatory requirements as well as the objectives of the business. This position requires to collaborate with other functions (R&D, Quality, Operations, etc.) and external consultants.
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.
Provides regulatory leadership to assigned product development program teams by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.
Reviews and approves labels, labeling, and promotional materials.
Review’s product design and change documentation, performs regulatory assessments, and implements required regulatory actions.
Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
Participates in the development and review of performance evaluation plan and report
Reviews analytical protocols and clinical protocols to assure collection of appropriate data for regulatory submissions
Works with business and cross-functional team to ensure alignment of global regulatory strategies with business objectives and implementation of the strategic plans.
Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for submissions to international regulatory bodies.
Draft and prepare US 510(k) submissions and EU IVDR Technical Documentation Submissions and lead submission process through clearance/approval.
Prepares, submits, and lead FDA pre-submissions.
Coordinates interactions/negotiations with U.S. and EU regulatory agencies.
Responsible for writing and updating standard operating procedures (SOP) and work instructions (WI) to support the implementation of IVDR.
Conduct training on IVDR requirements, new SOP’s and WI’s
Identifies and communicates potential risks and mitigations associated with reg. strategies.
Bachelor's degree required, strongly preferred in science and engineering
Minimum 5 years’ experience in regulatory affairs in the device/diagnostic industry. IVDR/MDR experience a plus.
Working knowledge of US and EU In Vitro Diagnostic or Medical Device Regulatory requirements.
Demonstrated experience in authoring FDA 510(k), leading pre-submission meetings, and interact with FDA to obtain clearance. Experience in authoring Tech files and working with Notified Bodies to obtain approval is a plus.
Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization.
Demonstrated ability to interpret and implement new regulations.
Demonstrated ability to project manage regulatory submissions.
Demonstrated ability to prioritize competing priorities and deadlines and organize complex information.
Spanish speaking/reading skills a plus!
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Employment at BD is contingent upon the Company’s receipt of sufficient proof that you are or will be fully vaccinated against COVID-19. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
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 - San Jose
What makes a successful Regulatory Affairs Professional at BD? Check out the top traits we’re looking for and see if you have the right mix.
- Skilled presenter
Advancing the world of health™
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. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care.
At BD, we are committed to global inclusion and diversity. Increased inclusion and diversity drives innovation, allows us to better understand patient and customer needs, and ultimately makes BD the best possible place for all associates to thrive.
Staff Regulatory Affairs Specialist
I love working with high powered leaders on a day to day basis who are respectful to my opinion and who I was never exposed to in my past job.
Global Regulatory Operations Labeling Specialist
I have been trusted in my ability to lead exciting and challenging projects with excellent upper management support. This in-turn has allowed me to grow and expand my regulatory knowledge that I believe will lay as a foundation to build my Regulatory career on.
Nikita A Mahendra Kumar
Senior Regulatory Affairs Specialist