Global Regulatory Affairs Specialist – MedTech

Becton, Dickinson and Company; Franklin Lakes (NJ); On-site; USD 136,000 - 217,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Paid time off

Job summary

Becton, Dickinson and Company in the United States (NJ - Franklin Lakes) is seeking a Staff Regulatory Affairs Specialist to lead regulatory activities for PreAnalytiX and Lab Specimen Management products. You will drive submissions, interact with FDA and Notified Bodies, and guide product lifecycle from development to launch across US, EU, and ROW.

The ideal candidate has a strong regulatory background, 5 years of experience in medical devices/IVD, and proven ability to work independently and

Qualifications

• B.S. in a scientific/health/technical field required.
• At least 5 years of regulatory affairs in medical device or IVD.
• Strong technical writing and cross-functional collaboration skills.

Responsibilities

• Coordinate and prepare US submissions including 510(k)/De Novo.
• Lead regulatory strategies for EU CE marking and global registrations.
• Review labeling and promotional materials for regulatory compliance.
• Collaborate with cross-functional teams across R&D, QA, and manufacturing.

Skills

Regulatory affairs

Cross-functional collaboration

Technical writing

MS Word

MS Excel

MS PowerPoint

Education

B.S. degree in a scientific/health/technical field

Job description

Becton, Dickinson and Company in the United States (NJ - Franklin Lakes) is seeking a Staff Regulatory Affairs Specialist to lead regulatory activities for PreAnalytiX and Lab Specimen Management products. You will drive submissions, interact with FDA and Notified Bodies, and guide product lifecycle from development to launch across US, EU, and ROW.

The ideal candidate has a strong regulatory background, 5 years of experience in medical devices/IVD, and proven ability to work independently and