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 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. 

The Sr. Regulatory Affairs Specialist is responsible for leading a variety of regulatory activities focusing on IVDR Sustaining projects. This role requires an understanding of the IVDR regulatory framework and processes, to primarily support the maintenance of CE IVD technical documentation. Tasks and deliverables for this role include regular updates to device technical files, regulatory assessment for product changes, registration file updates across systems, development and updates to internal procedures, and other related activities (e.g., UKCA transition).

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.

• Leads and prepares high-quality regulatory submissions such as EU Technical Documentation (IVDR) with limited supervision.

• Review product labelling and instruction for use to ensure compliance with IVDR.

• Review regulatory content for completeness, accuracy, consistency, and clarity.

• Conduct regulatory assessments for changes to products and processes.

• Develop and update files to fulfill UKCA regulations.

• Develop and update standard operating procedures (SOPs) and work instructions (WIs) for regulatory processes and compliance.

• Provide support to remediation projects, audits, and regulatory teams as needed.

• Provide support to Regulatory Affairs Leadership for related duties and assignments as required

Education and Experience:

• B.S. degree in health science or life science field (biomedical engineering, engineering, computer science, biology, medical technology, etc.) RAC Certification is a plus.

• 3 years of regulatory submissions experience and/or working in environments regulated to European Medical Device Regulations, U.S. FDA, and/or ISO standards.

• Experience in Flow Cytometry is a plus

Minimum Qualifications:

• High attention to detail, with emphasis on accuracy, completeness, and new information

• Ability to prioritize multiple tasks, schedule work to meet business needs, and adapt to dynamic environments to keep pace with tight deadlines.

• Excellent organizational and planning skills, including process savvy, action oriented, and focused on impactful results.

• Excellent analytical problem solving ability to identify areas of concern and optimize outcomes

• Excellent interpersonal skills, both written and verbal, to communicate with diverse teams for effective interactions with technical personnel (scientific and legal). 

• Strong computer literacy (SAP, Veeva, SalesForce, Microsoft Word / Excel / Teams / PowerPoint)

• Familiar and/or experience with regulatory requirements for IVD manufacturers such as design control requirements, change notifications, device listings, site registrations, etc.

• Excellent project management, negotiation, communication (written and verbal) and social skills; ability to communicate and work in a team with varied environments effectively

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