Job Description
The Regulatory Affairs Specialist (Innovation) is responsible for providing regulatory guidance, developing regulatory strategies, and conducting risk assessments, to new product development (NPD) teams for _in vitro_ diagnostic (IVD) products. This position will be responsible for preparing FDA submissions, including, but not limited to: Pre-IDEs, PMA, PMA Supplements, De Novo Petitions, 510(k) submissions, and CLIA Waiver applications, as well as EU IVDR Technical Files/Dossiers.
Responsibilities:
- Serves as Regulatory Affairs SME on various new product development (NPD) teams
- Works cross-functionally with R&D, Medical Affairs, Quality, Marketing, Program Management and other key organizational functions
- Recognizes and addresses potential regulatory risks with project plans
- Responsible for organizing and leading various FDA & EU IVDR submissions
- Serves as contact to FDA and Notified Body review teams during submission reviews/communication
- Recognizes and proposes continuous process improvements.
Required Education and Experience:
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related scientific/technical discipline (Equivalent combination of education and relevant experience may be considered)
- Minimum 5 years of directly related regulatory experience in the _in vitro_ diagnostic device and/or medical device area(s)
Preferred Skills and Experience:
- RAPS Certification preferred
- Demonstrated experience in interpreting subjective and complex aspects of specific regulations
- Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes
- Demonstrated success in supporting product development and product support projects, including complex projects involving ambiguity and rapid change
- Demonstrated success in preparing, filing and/or completing (including negotiations) regulatory submissions
Skills
- Ability to analyze complex issues and to formulate sound approaches to resolving/addressing issues
- Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
- Ability to handle multiple tasks and to prioritize and schedule work to meet business needs. Minimal supervision required.
Technical & Functional:
- Experience coordinating cross-functional inputs (i.e. R&D, Quality, Medical Affairs, Program Management, Marketing)
- Ability to compile and review documentation to support FDA submissions and EU IVDR documentation
- Understanding of regulatory submission processes and lifecycle management
Communication & Collaboration:
- Strong written and verbal communication skills
- Experience working with cross-functional, fast-moving teams
- Confidence in speaking up within cross-functional teams when regulatory risks are present
Process & Compliance:
- Familiarity with SOPs, regulatory procedures, and quality systems (e.g., ISO 13485)
- Ability to identify and support process improvements
Other:
- Strong organizational skills and ability to manage multiple submissions/projects simultaneously
- Adaptability to changing timelines and priorities
- Proficiency in Microsoft Office tools (Excel, Word, PowerPoint)
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance.
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?
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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
**To learn more about BD visit** _https://bd.com/careers_.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally-protected characteristics.
