Regulatory Affairs Specialist

Job Description Summary

Regulatory Affairs (RA) Specialist will provide primary RA support for one or more product lines and/or regions. Duties include independent participation on new product development teams and continued RA support throughout the product lifecycle. The specialist prepares regulatory submissions required to market new or modified medical devices in global markets and interprets regulatory issues to inform business decisions.

BD is a global medical technology company dedicated to advancing health. We foster an environment that supports learning, growth, and innovation, encouraging employees to become the makers of possible.

• Understand global regulatory requirements and pathways.
• Understand scientific and health principles related to product development and regulations.
• Act as regulatory lead on core teams, guiding product development on regulatory requirements.
• Organize materials from preclinical and clinical studies for review; assist in the review process.
• Prepare dossiers and submission packages for regulatory agencies.
• Support development of regulatory strategies for marketing authorization in domestic and global markets.
• Review product changes to ensure regulatory compliance, assess impacts on US and CE Mark, and prepare notifications.
• Prepare and send post‑market reports and submissions.
• Train colleagues in areas of expertise.
• Interpret data, draw conclusions, and identify trends.
• Review advertising and promotional material.
• Maintain regulatory databases and systems.
• Prepare system effectiveness reports and summaries.
• Participate in regulatory body audits as needed.

• Bachelor’s or advanced degree in biology, chemistry, engineering, or a medical-related field with at least one year of regulatory experience in the Medical Device industry.
• 5–7 years of explicit regulatory experience may be considered in lieu of education.
• Ability to plan and schedule multiple priorities concurrently.
• 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 accurate in handling regulatory information and submissions.
• Ability to work independently with minimal supervision.
• Experience supporting regulatory body audits.
• Experience with regulatory tools and systems.
• Excellent writing and strong organizational skills.

Regularly required to stand, walk, sit, use sight, and use hands to manipulate objects, tools, and office equipment. Occasionally required to reach with hands and arms and stoop, kneel, or crouch. Reasonable accommodations available upon request.

Open cubicle setting in a fast‑paced, team‑oriented environment. BD is an affirmative action, equal opportunity employer that values diversity.

Minimum of 4 days in‑office per week; remote or field arrangements may vary by role and will be indicated in the posting.

Employment may be contingent on proof of full vaccination against COVID‑19. Testing may be available or required in some locations. Accommodation requests considered per applicable law.

BD offers a culture that values authenticity, accountability, and continuous improvement. Employees learn, grow, and thrive while contributing to a healthier world.

Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military eligibility, or veteran status.

Primary

Work Location:

USA AZ – Tempe Headquarters.

Work Shift:

To be determined.