About the position
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 Staff Regulatory Affairs Specialist is part of the team responsible for Core Business New Product Development with a focus on compliance to regulations from the US Food Drug & Administration (FDA) and the EU In Vitro Diagnostic Regulation (IVDR). This individual will be responsible for leading the regulatory support for IVD and CDx new product development, developing global regulatory strategies, submissions to FDA and an EU notified body, maintenance of legacy products, and special projects. Furthermore, this individual is responsible for, reviewing policies, guidance documents and procedures; applying best practices; and collaborating with cross-functional teams (e.g., R D, Quality, Clinical Operations, etc.) within the business units to support the total product lifecycle.
Responsibilities
- Serves as the RA Subject Matter Expert (SME) in new product development team(s) by providing regulatory guidance, such as anticipating regulatory obstacles and emerging issues; identifying solutions, through the product development cycle; and coordinating cross functional team inputs.
- Assesses and documents regulatory pathways for new products and product modifications while working with cross-functional teams to ensure alignment of the global regulatory strategy with business objectives and implementation of the strategic plan.
- Identifies and communicates potential risks and mitigations associated with the regulatory strategy and submission.
- Reviews and approves of design control related documents and labels, labeling, and promotional materials.
- Leads and prepares high-quality regulatory submissions such as Pre-Submissions, IDEs, 510(k)s, De Novo, PMAs and/or EU Technical Documentation (IVDR) with limited supervision.
- Coordinates interactions/negotiations with U.S. and EU regulatory agencies.
- Obtains approval from health authority(ies) with desired claims, per project plan.
- Serves as RA SME for product change requests conducting regulatory assessments, and implementing required regulatory actions (e.g., authors Letters to File and/or updates technical document).
- Leads annual reviews with internal/external audits.
- Leads implementation of department procedures and maintaining regulatory requirements.
- Responsibilities will entail problem solving of complex issues, involvement in a diverse scope of project results, data analysis, and ownership of task execution and completion.
- Mentor junior staff of regulatory professionals and conduct training on regulatory subject.
- Provides support to Sr. RA manager and RA leadership, supports other RA teams (e.g., EU and international) when required, and performs other related duties and assignments as required.
Requirements
- 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.
Nice-to-haves
- RAC Certification is a plus.
- Flow cytometry experience is a plus.
- CDx experience is preferred.
Benefits
- Competitive salary and benefits package.
- Opportunities for professional development and training.
- Supportive work environment that encourages growth and learning.
