Regulatory Affairs Specialist

Job Description Summary

The Regulatory Affairs (RA) Specialist will provide primary RA support for one or more product lines and/or region(s), including independent participation on new product development teams and continued RA support through the lifecycle of the product. The RA Specialist will also prepare regulatory submissions required to market new or modified medical devices in global markets. The RA Specialist is able to interpret and communicate regulatory issues to ensure the business is aware of opportunities, risks, and concerns.

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 Med Tech 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.

• Understands fundamental global regulatory requirements and different regulatory pathways.
• Understands scientific and health principles related to healthcare product development and regulations.
• Participates in core teams as regulatory lead, and provides guidance on regulatory requirements to product development teams, with some support from management.
• Organizes materials from preclinical and clinical studies for review and assists in the review process.
• Assists and/or has ownership in preparation of dossiers and submission packages for regulatory agencies.
• Supports development of regulatory strategies for marketing authorization for domestic and/or global markets.
• 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.
• Assists in the preparation and sending of post-market reports and submissions.
• Participates in training of colleagues, as needed, for areas of expertise.
• Demonstrates data interpretation skills to provide solutions, draw conclusions and identify trends.
• Independently reviews advertising and promotional material for respective product line(s) and/or region(s) as needed.
• Maintains regulatory databases/systems with key regulatory data for respective product line(s) and/or region(s).
• Assists in the preparation and sending of system effectiveness reports and summaries related to regulatory systems and tools, as applicable.
• May participate in regulatory body audits, as related to respective product line(s) and/or region(s).

• Bachelor’s degree or Advanced degree in technical area such as biology, chemistry, engineering or medical-related field AND a minimum of one year of experience in a Regulatory role within the Medical Device industry.
• Will consider 5-7 years explicit Regulatory experience within the Medical Device industry in lieu of education.
• Ability to plan and schedule multiple priorities in a concurrent fashion.
• Ability to review, collate, and summarize scientific and technical data.
• Ability to learn new technical concepts and skills.
• Good problem solving and analytical skills.
• Good written and oral communication skills.

• Detail-oriented, methodical, and able to handle regulatory information and submissions with a high degree of accuracy.
• Ability to complete work with minimal supervision and ability to work independently.
• Previous experience in regulatory body audit support.
• Experience with regulatory tools and systems.
• Excellent writing and strong organizational skills.

Performing the duties of this job, the employee is regularly required to stand, walk, sit, use sight, and use hands to manipulate, handle or feel objects, tools, controls, and office equipment. The…