Global Regulatory Affairs Lead, Medical Devices & IVD

BD; Arizona; Sur place; USD 136 000 - 217 000; Plein temps

Avantages offerts par ce poste

Health insurance

Retirement plan

Paid time off

Educational assistance

Résumé du poste

BD is seeking a Staff Regulatory Affairs Specialist in the USA (NJ) to lead regulatory strategies and submissions for PreAnalytiX and Lab Specimen Management products. You will guide cross-functional teams across US, EU, and ROW from development through launches, ensuring compliance and timely approvals.

Ideal candidates have strong medical device/IVD regulatory backgrounds, with experience in 510(k), PMA, CE marking, and global registrations.

Qualifications

• B.S. degree in 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 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.

Responsabilités

• Coordinate and prepare premarket US FDA submissions (510(k), Pre-Sub, De Novo) and liaise with FDA.
• Assess necessity for 510(k) submissions for device modifications and justify when not required.
• Prepare technical files for CE marking with input from R&D, Quality, Manufacturing, and Medical Affairs.
• Lead regulatory guidance across product development and lifecycle.
• Identify regulatory risks and mitigation approaches for partners.
• Manage NOC/International regulatory assessments to align US/EU/ROW requirements.
• Develop regulatory strategies for Change Controls and Regulatory Requirements.
• Support global regulatory strategies with international teams.
• Lead regulatory efforts for EU MDR/IVDR and other standards.
• Review and approve product labeling, advertising materials for regulatory compliance.
• Coordinate responses to customer information requests and maintain FDA listings/registrations.
• Develop SOPs, work instructions, and policies to maintain compliance.
• Represent BD in regulatory standards bodies and drive improvements.
• Identify ways to improve current processes and implement changes.

Connaissances

Regulatory affairs experience

Technical writing

Cross-functional collaboration

Confidentiality handling

Influencing without authority

Formation

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

Outils

Microsoft Word

Microsoft Excel

PowerPoint

Description du poste

BD is seeking a Staff Regulatory Affairs Specialist in the USA (NJ) to lead regulatory strategies and submissions for PreAnalytiX and Lab Specimen Management products. You will guide cross-functional teams across US, EU, and ROW from development through launches, ensuring compliance and timely approvals.

Ideal candidates have strong medical device/IVD regulatory backgrounds, with experience in 510(k), PMA, CE marking, and global registrations.