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. 

Job Overview

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.

Job Responsibilities:
Activities Include but are not limited to the following:

• 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.

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.

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 each other be great, we do what’s 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, you’ll 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 https://bd.com/careers

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. 

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At BD, we are strongly committed to investing in our associates—their 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.

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