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.

EDUCATION AND EXPERIENCE:

• B.S. degree required with a focus in health science or life science field (e.g., biomedical engineering, engineering, computer science, biology, medical technology, chemistry or related science, etc.) preferred.
• Requires a minimum of 5 years’ experience in regulatory affairs in the device/diagnostic industry.
• Demonstrated experience in authoring a PMA, De Novo, 510(k), leading pre-submissions, and interact with FDA to obtain clearance, preferably an IVD.
• Demonstrated experience in authoring a IVDR Technical Document and interacting with a Notified Body for certification.
• Ability to interpret new regulations and understand and interpret IVD regulatory requirements.
• RAC Certification is a plus.
• Flow cytometry experience is a plus.
• CDx experience is preferred.

KNOWLEDGE AND SKILLS:

• A minimum 5 years of U.S. submission and EU Technical Documentation experience for IVD instruments, software, and/or reagents.
• Experience with regulatory requirements for IVD manufacturers such as design control requirements, change notifications, device listings, site registrations, etc.
• Experience with IVD instruments and software requirements, specifically around cybersecurity, machine learning, or artificial intelligence.
• Excellent project management, negotiation, communication (written and verbal) and social skills; ability to communicate and work in a team with varied strengths; effective interactions with technical personnel (scientific and legal).
• Ability to handle multiple tasks and to prioritize and schedule work to meet business needs.
• Detail oriented, with emphasis on accuracy and completeness. Including the ability to write high quality submission or internal documentation.
• Excellent team skills with ability to influence others without authority.
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices. This includes analytical problem solving.
• Ability to identify areas of concern in moderately complex projects and lead changes.
• Demonstrated organizational and planning skills, including process savvy, committed, focused urgency and working towards results.
• Computer literacy (SAP, Microsoft Word / Excel / PowerPoint).
• Information literacy, the ability to recognize when information is needed, locate relevant information, evaluate its quality, and effectively use it for decision-making, problem-solving, or knowledge acquisition.
  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. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
  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.

Please refer the Job description for details