Global Regulatory Affairs Specialist — Medical Devices

Regulatory Jobs; Franklin (NJ); On-site; USD 136,000 - 217,000; Full time

Job summary

Becton, Dickinson and Company (BD) is seeking a Staff Regulatory Affairs Specialist to ensure continued market access for PreAnalytiX and Lab Specimen Management products in the US, EU, and other markets. The role involves regulatory strategy, submissions, and lifecycle support across multiple jurisdictions, with opportunities to lead international regulatory initiatives.

The ideal candidate has a strong regulatory background, excellent technical writing skills, and the ability to work

Qualifications

• B.S. degree in a scientific, health sciences or technical discipline required (e.g., engineering, bioengineering, biology, chemistry)
• 5 years of Regulatory Affairs experience in medical device or in vitro diagnostic device companies.
• Proficient in Technical writing skills and be proficient at compiling successful submissions for the appropriate audience
• Experience maintaining confidentiality in dealing with regulatory and clinical documentation
• Experience with cross-functional collaboration and teamwork skills including influencing without authority
• Proficient in using Microsoft Word, Excel, PowerPoint

Responsibilities

• Coordinate, prepare, and complete regulatory submissions to FDA and other authorities.
• Develop regulatory strategies to support product life cycle and changes.
• Lead regulatory activities for 510(k), PMA, CE marking, and other filings as applicable.
• Review labeling and promotional materials for regulatory compliance.
• Collaborate with R&D, Quality, and Marketing to ensure regulatory readiness.
• Maintain FDA listings and facility registrations; support international registrations.

Skills

Regulatory affairs

Technical writing

Cross-functional collaboration

Microsoft Office

Education

B.S. degree in science/engineering/technical discipline

Tools

Microsoft Word

Excel

PowerPoint

Job description

Becton, Dickinson and Company (BD) is seeking a Staff Regulatory Affairs Specialist to ensure continued market access for PreAnalytiX and Lab Specimen Management products in the US, EU, and other markets. The role involves regulatory strategy, submissions, and lifecycle support across multiple jurisdictions, with opportunities to lead international regulatory initiatives.

The ideal candidate has a strong regulatory background, excellent technical writing skills, and the ability to work