Senior Regulatory Affairs Specialist (hybrid)

**Job Description Summary** **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 its no small feat. It takes the imagination and passion of all of usfrom design and engineering to the manufacturing and marketing of our billions of MedTech products per yearto 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 youll be supported to learn, grow and become your best self. Become a **maker of possible** with us. In BD Specimen Management (BD SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career. Our Senior Regulatory Affairs Specialist position is primarily focused on maintaining continued market access of our existing product portfolio, in addition to opportunities to provide regulatory support for new product development projects. The ideal candidate will be energetic, possess a strong regulatory background and performs well independently and as part of a team. **Job Overview:** The Senior Regulatory Affairs Specialist will work in BD Specimen Management providing regulatory leadership to cross-functional project teams from early development to new product launches in various markets including the US, EU, and others. The incumbent will support product lifecycle management activities for Lab Specimen Management products, including assessments of the regulatory impact of product changes and line extensions. The incumbent may also develop and execute regulatory strategies to support new 510(k) submissions, CE marking applications, and support our international regulatory team in further launch activities. The ideal candidate will have medical device and in vitro diagnostic experience in the US and EU, as well as experience with project management activities. _Our people make all the difference in our success. Join us in our mission to advance the world of health._ **_This is a hybrid position where the candidate is required to be in the office a minimum of 3 days a week. Office location is either Franklin Lakes, NJ or Sparks, MD._** **Education and Experience:** + B.S. degree in a technical discipline (e.g., engineering, bioengineering, biology, chemistry) or project management. + Minimum 3 years Regulatory Affairs and/or Project Management experience in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree. + Demonstrated ability to lead a cross-functional team to consistently meet project timelines. **Knowledge and Skills:** + Proficient in using Microsoft Word, Excel, PowerPoint, and Project. + Strong communication (written, oral) and project management skills. + Able to handle multiple competing tasks with great attention to detail. + Able to work independently to achieve objectives on or before schedule. + Demonstrated cross-functional collaboration and teamwork skills including influencing without authority. + Comprehensive knowledge of medical device regulations and standards. + Current knowledge of European quality system standards, and requirements under EU MDR and IVDR preferred. + Ability to navigate ambiguous regulatory requirements and standards interpretation. For certain roles at BD, employment is contingent upon the Companys 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 BDs 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. Its also a place where we help each other be great, we do whats 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, youll 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? 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. #earlycareer **Primary Work Location** USA NJ - Franklin Lakes **Additional Locations** USA MD - Sparks - 7 Loveton Circle **Work Shift** At BD, we are strongly committed to investing in our associatestheir 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** $103,500.00 - $170,800.00 USD Annual 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.

Created: 2024-10-28