Job Description Summary

　　BD Biosciences, as part of BD, is an industry leader in flow cytometry area. We are recruiting for a Regulatory Affairs Specialist to join our Team. The Regulatory Affairs Specialist is responsible for supporting a variety of regulatory activities focusing on the IVDR sustaining project, with oversight from senior regulatory staff. This role requires understanding of the current IVDR regulatory framework and processes, to primarily support the maintenance of CE IVD technical documentation as well as tasks and deliverables such as regulatory assessment for product changes, develop and update new procedures, registration file maintenance, organization and update, and other related activities (e.g., UKCA transition).

　　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.

　　Job Responsibilities:

　　Activities include but are not limited to the following:

　　Maintenance of Technical Documentation in accordance with the requirements of IVDR (EU) 2017/746, including but not limited to document updates, management of regulatory information in databases, and navigating document control systems.Review regulatory content for completeness, accuracy, consistency, and clarity.Conduct regulatory assessments for changes to products and processes.Develop and update standard operating procedures (SOPs) and work instructions (WIs)Review product labelling and instruction for use to ensure compliance with IVDR.Develop and update files to fulfill UKCA regulations.Support remediation projects, new product teams, and US team as needed.Support RA e-Systems and manage data structure within various RA systems.Identifies and communicates potential risks and mitigations associated with regulatory strategies.Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.Provides support to Regulatory Affairs Leadership, and performs other related duties and assignments as required.

　　Minimum Qualifications:

　　Education and Experience:

　　B.A. or B.S. degree in health science or life science field (biology, microbiology, chemistry, engineering, medical technology, etc.), or B.A. or B.S. degree in other related subject area with significant coursework in biology and chemistry.1 year experience working in an U.S. FDA/ or ISO regulated environment or relevant educational experience.Detail oriented, with emphasis on accuracy and completeness.Ability of analytical problem solvingAbility to handle multiple tasks and to prioritize and schedule work to meet business needs.Ability to identify areas of concern in complex projects and manage changes.Demonstrate organizational and planning skills, including process savvy, action oriented, focused urgency and driving for results.Excellent interpersonal skills, ability to communicate and work in a diverse team environment; effective interactions with technical personnel (scientific and legal). This includes excellent written and verbal communication skills.Ability to handle the stress of tight deadlines and a fast-paced work environment.Digital literacy (SAP, Microsoft Word / Excel / PowerPoint)

　　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.

　　PDN

　　Primary Work Location

　　USA CA - San Jose

　　Additional Locations

　　USA CA - San Diego (BDB)

　　Work Shift

　　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

　　$80,600.00 - $132,900.00