Senior Regulatory Affairs Specialist – MedTech (US/EU)

BD; Connecticut; On-site; USD 136,000 - 217,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) and retirement plans

Paid time off

DailyPay

Educational assistance

Parental leave

Commuter benefits

Pet insurance

Job summary

BD is seeking a Staff Regulatory Affairs Specialist to lead regulatory initiatives for PreAnalytiX and Lab Specimen Management products. You will guide regulatory strategy, coordinate US FDA submissions, and collaborate across R&D, Quality and Manufacturing to ensure compliance and timely market access in the US, EU and ROW.

Strong communication and project-management skills are essential. The role supports global regulatory strategies, contributes to lifecycle management, and ensures labeling

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 and compiling submissions for the appropriate audience.
• Experience with confidential regulatory and clinical documentation.
• Experience with cross-functional collaboration and influencing without authority.
• Proficient in Microsoft Word, Excel, PowerPoint.

Responsibilities

• Coordinate, prepare, and complete premarket applications to the US FDA (510(k), Pre-Sub, De Novo) and liaise with FDA on submissions.
• Assess necessity for 510(k) submissions for device modifications and prepare justifications.
• Coordinate and prepare technical files for CE marking with input from R&D, Quality, Manufacturing, Medical Affairs, etc.
• Lead regulatory teams and provide guidance throughout product development prior to submission.
• Develop regulatory strategies for changes and ensure regional requirements are captured.

Skills

Regulatory leadership

Cross-functional collaboration

Technical writing

Regulatory strategy

Regulatory submissions

Education

B.S. in a scientific/health sciences/technical discipline

Advanced Degree (preferred)

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

BD is seeking a Staff Regulatory Affairs Specialist to lead regulatory initiatives for PreAnalytiX and Lab Specimen Management products. You will guide regulatory strategy, coordinate US FDA submissions, and collaborate across R&D, Quality and Manufacturing to ensure compliance and timely market access in the US, EU and ROW.

Strong communication and project-management skills are essential. The role supports global regulatory strategies, contributes to lifecycle management, and ensures labeling