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 independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. They participate on cross-functional teams, lead the development of global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies, review design control documents and product labeling, and evaluate proposed device changes. The Sr. Regulatory Affairs Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns, and provides recommendations to minimize risk.

Job Responsibilities

• Represents Regulatory Affairs on product development teams to support new product development and change control to ensure US, EU, and other global regulatory requirements are met.

• Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market.

• Reviews and approves design control documentation and product labeling in consideration of US, EU, and other global regulatory requirements.

• Authors FDA submissions, EU technical files, and other regulatory documents for submission to regulatory bodies for product review and approval.

• Point of contact for FDA, EU notified bodies, and other regulatory agencies on submissions and other issues.

• Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications. 

• Communicates changes to global regions and supports preparation of global notifications as needed.

• Understands fundamental global regulatory requirements and different regulatory pathways.

• Stays informed of new regulations and changes to existing regulations and communicates to project teams.

• Maintains regulatory databases and systems

• Mentors other regulatory colleagues

Requirements:

• Bachelor's degree or higher, preferably in a scientific discipline

• Master's degree in Regulatory Affairs preferred

• Regulatory Affairs Professional Society (RAPS) certification preferred

• 4 years Regulatory Affairs experience in the medical device industry preferred

Knowledge & Skills:

• Excellent written and verbal communication skills

• Excellent problem solving and analytical skills

• Detail-oriented, with a focus on accuracy and completeness

• Excellent organization skills; able to manage multiple tasks and meet timeline commitments

• Ability to work in a team-oriented, fast-paced environment

• Demonstrated ability to analyze, interpret, review, and summarize scientific, technical, and regulatory information

• Comprehensive understanding of global medical device regulations, with in-depth knowledge of US and EU requirements

• Experience working with FDA, EU notified bodies, and other regulatory agencies

• Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions.

• Knowledge of product development and medical device quality system regulations.

• Experience with product development processes and design control.

• Ability to mentor and teach other regulatory associates

• Proven prior experience required owning and managing the end-to-end process of authoring, submitting and obtaining regulatory approvals/clearances (510(k)s), including addressing and responding to deficiencies from regulatory agencies.

• Proficient in use of Microsoft Office tools (including Word, Excel, PowerPoint)

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in th