Senior Regulatory Affairs Specialist, Medical Devices & IVD

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

Benefits offered by this job

Medical benefits

401(k) plan

Paid time off

Dental & Vision

Job summary

BD is a global medical technology leader focused on advancing health. The Staff Regulatory Affairs Specialist will lead regulatory activities for PreAnalytiX and Lab Specimen Management portfolios, supporting 510(k), CE marking, and global registrations across US, EU, and ROW.

The role requires a strong regulatory background, experience with medical devices/IVDs, and the ability to work independently and in teams on product changes and new launches.

Qualifications

• B.S. degree in scientific, health sciences or technical discipline required.
• 5 years of Regulatory Affairs experience in medical device or in vitro diagnostic device companies.
• Proficient in Technical writing and compiling successful submissions.
• Experience maintaining confidentiality in regulatory and clinical documentation.
• Experience with cross-functional collaboration and teamwork including influencing without authority.
• Proficient in using Microsoft Word, Excel, PowerPoint.

Responsibilities

• Coordinate, prepare, and complete premarket applications to the US FDA (510(k), PMA, De Novo).
• Assess need for 510(k) submissions for device modifications and prepare justifications.
• Prepare technical files for CE marking with Notified Bodies.
• Lead regulatory discussions and provide guidance to cross-functional teams.
• Develop and execute regulatory strategies for Change Controls and lifecycle activities.

Skills

Regulatory Affairs

Technical Writing

Cross-functional Collaboration

Confidentiality

Education

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

Advanced Degree

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

BD is a global medical technology leader focused on advancing health. The Staff Regulatory Affairs Specialist will lead regulatory activities for PreAnalytiX and Lab Specimen Management portfolios, supporting 510(k), CE marking, and global registrations across US, EU, and ROW.

The role requires a strong regulatory background, experience with medical devices/IVDs, and the ability to work independently and in teams on product changes and new launches.