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 SummaryThe Sr. Regulatory Affairs Specialist will be responsible for the preparation of regulatory submissions in accordance with EU IVDR and other related activities. This position requires candidate to collaborate with other functions (R&D, Quality, Operations) and external consultants. Experience in project management is preferred.
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 Description :
- Understand and interpret EU in vitro diagnostic device (IVD) regulatory requirements
- Draft and prepare product technical files compliant to EU IVDR
- Represent RA in IVDR core team and identify regulatory activities for project schedule
- Work with Notified Body and provide timely responses to their questions in order to obtain approval of Technical Documentations
- Be responsible for drafting 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
- Review analytical and clinical performance protocols and reports to assure collection of appropriate data for regulatory submissions
- Participate in the development and review device performance evaluation plan and report
- Review product labels and IFUs compliant to IVDR
- Work with cross-functional teams to assess and implement changes to meet regulations
- Bachelor's degree required strongly preferred in science or engineering. Master's degree preferred.
- Minimum 3 years’ experience in regulatory affairs in the device/diagnostic industry. IVDR/MDR experience a plus.
- Demonstrated experience in authoring Tech files and collaborating with Notified Bodies to obtain approval. 510(k) experience a plus
- Demonstrated ability to project lead regulatory submissions
- Demonstrated ability to interpret and implement new regulations
- Working knowledge of EU in vitro diagnostic or medical device regulatory requirements and quality system standards
- Ability to effectively communicate both verbally and in writing to all levels within the organization and external to the organization
- Ability to prioritize, multi task, and organize work
Click on Apply if this sounds like you!
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/
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