Job Description SummaryAs Senior Regulatory Affairs Specialist, you will assist in the analysis and improvement of existing regulatory processes through regulatory activity immersion.Job DescriptionWe are the makers of possibleBD 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.Primary Responsibilities:
Support regulatory efforts required to comply with new and existing regulations (e.g., FDA Medical Device Regulations and Guidelines, MDSAP) and other requirements including changes to FDA guidelines and applicable international standards
Leading efforts for UDI including US, EU, and International requirements
Support efforts for Technical File creation and remediation, collaborating with cross-functional teams for required content
Support regulatory impact assessments for change controls and other RA/QA items
Collect, store, and maintain regulatory documentation and assists in managing the data structure of the regulatory network (PIM, DMS, etc.)
Proven ability to interpret medical device Quality System Regulations
Assists in preparing, auditing, editing, and publishing registration documentation, as needed
Support business export control (BEC) listing of product for release globally per RA requirements
Support the review and approval of product labeling, promotional, and advertising materials as needed
Performs other duties and assignments as required
To be successful in this role, we require:
Knowledge of global Regulatory Affairs requirements and registrations
Strong organizational skills
Strong prioritizing, interpersonal, communication, and analytical skills and the ability to multi-task disparate projects
Ability to represent Regulatory Affairs in multiple environments (i.e., Marketing, R&D, etc.) and work with all levels of management
Read, analyze, and interpret regulatory literature and documents while effectively communicating information to peers and management while working independently with minimum supervision
Identify and communicate risks and mitigations associated with global regulatory strategies to cross-functional collaborators
Education and experience required:
Minimum bachelor’s degree, preferably Master’s degree in RA, QA, or life sciences
Minimum of 2 years of Regulatory Affairs experience in medical devices
Regulatory and Quality Information Management systems such as SAP, RIM, or related systems experience preferred
Digital literacy (MS office: Word, Excel, PowerPoint, Teams; Regulatory E-Systems)
RAC certification preferred
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/careersBecton, 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.#earlycareerPrimary Work LocationUSA CA - San Diego Bldg A&BAdditional LocationsWork ShiftAt 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 (https://jobs.bd.com/benefits) .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$99,000.00 - $163,300.00 USD AnnualBecton, 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.
