Regulatory Affairs Specialist

Job Description

The Regulatory Affairs Specialist at Becton, Dickinson and Company is responsible for supporting the preparation and submission of regulatory documents to health authorities, ensuring compliance with global regulations for medical devices.

• Prepare and submit regulatory filings (e.g., 510(k) s, Technical Files, Design Dossiers, PMAs) to global health authorities in accordance with applicable regulations and company procedures.
• Review and assess proposed product changes for regulatory impact and ensure timely updates to existing regulatory submissions.
• Support the development and maintenance of regulatory strategies for new product development and existing product lines.
• Collaborate with cross-functional teams (e.g., R&D, Quality, Marketing, Clinical) to ensure regulatory requirements are integrated throughout the product lifecycle.
• Participate in internal and external audits and inspections, providing regulatory expertise and documentation as needed.
• Monitor and interpret new and evolving global regulations, standards, and guidance documents relevant to medical devices.
• Maintain accurate and organized regulatory documentation and databases.
• Assist in responding to regulatory agency inquiries and requests for information.
• Provide regulatory support for post‑market surveillance activities, including adverse event reporting and recall support.

• Bachelor’s degree in a scientific discipline (e.g., Biomedical Engineering, Biology, Chemistry, Pharmacy) or related field.
• 1+ years of experience in the medical device industry.
• Demonstrated understanding of global medical device regulations (e.g., FDA 21 CFR Part 820, EU MDR/IVDR, Health Canada, TGA).
• Experience with preparing and submitting regulatory filings (e.g., 510(k) s, CE Mark Technical Files).
• Strong analytical, problem‑solving, and decision‑making skills.
• Excellent written and verbal communication skills, with attention to detail.
• Ability to work independently and as part of a team in a fast‑paced environment.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• RAC certification is a plus.

• Medical coverage, Health Savings Accounts, Flexible Spending Accounts, Dental coverage, Vision coverage, Hospital Care Insurance.
• Critical Illness Insurance, Accidental Injury Insurance, Life and AD&D insurance, Short‑term and Long‑term disability coverage.
• Long‑term care with life insurance.
• Paid time off (PTO), all required State leaves, educational assistance/tuition reimbursement.
• Retirement benefits including 401(k) Plan, deferred compensation, and 529 College Savings Plan.
• Well‑being programs such as anxiety management, wellness incentives, sleep improvement, and emotional/mental health support.

USA, NJ – Franklin Lakes (Primary Work Location)

$84,300.00 – $ USD Annual

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, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.