Regulatory Affairs Lead, Medical Devices & IVD

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

Avantages offerts par ce poste

Health & Well-being

Retirement & Financial Well-being

Work-Life Balance & Family Support

Leave Programs

Résumé du poste

BD (Becton, Dickinson, and Company) is seeking a Staff Regulatory Affairs Specialist to lead regulatory activities for PreAnalytiX and Lab Specimen Management products across the US, EU, and other markets. You will partner with cross-functional teams to ensure regulatory compliance through product changes, new launches, and lifecycle management.

The role emphasizes strong regulatory background, collaboration, and independent work, with global responsibility for submissions and registrations in

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 intended audience
• Experience maintaining confidentiality in regulatory/clinical documentation
• Experience with cross-functional collaboration and teamwork, including influencing without authority
• Proficient in MS Word, Excel, PowerPoint

Responsabilités

• 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
• Prepare technical files for CE marking with input from R&D, Quality, Manufacturing, etc.
• Lead regulatory considerations within cross-functional teams through product development to launch
• Quantify regulatory risks and propose mitigation strategies
• Manage change control assessments for regulatory strategy across regions
• Develop regulatory strategies for device change controls and lifecycle management
• Collaborate with international regulatory associates to register devices worldwide
• Lead efforts to meet EU MDR/IVDR and other regulatory updates
• Review product labeling and promotional materials for regulatory compliance
• Respond to customer information requests and ensure FDA listings and facility registrations
• Develop SOPs and policies to maintain compliance with applicable regulations
• Represent BD in external trade/regulatory standards groups
• Identify process improvements to increase efficiency

Connaissances

Regulatory affairs

Medical device knowledge

Technical writing

Project coordination

Formation

B.S. in science/engineering

Outils

Microsoft Word

Excel

PowerPoint

Description du poste

BD (Becton, Dickinson, and Company) is seeking a Staff Regulatory Affairs Specialist to lead regulatory activities for PreAnalytiX and Lab Specimen Management products across the US, EU, and other markets. You will partner with cross-functional teams to ensure regulatory compliance through product changes, new launches, and lifecycle management.

The role emphasizes strong regulatory background, collaboration, and independent work, with global responsibility for submissions and registrations in