Global Regulatory Lead – Medical Devices & IVD

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

Job summary

BD is seeking a Staff Regulatory Affairs Specialist to drive regulatory leadership for PreAnalytiX and Lab Specimen Management products across US, EU, and other markets. You will guide lifecycle activities, assess regulatory impacts of changes, and help shape strategies for 510(k) and CE marking submissions.

You'll collaborate with R&D, Quality, and Manufacturing, lead regulatory activities in cross-functional teams, ensure compliance with MDR/IVDR, and support international registrations while

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 in compiling successful submissions for the appropriate audience
• 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), Pre-Sub, De Novo) and liaise with FDA
• Assess necessity for 510(k) submission and prepare robust justifications
• Coordinate and prepare technical files for CE marking with input from R&D, Quality, Manufacturing, etc.
• Represent RA with leadership in complex product teams and provide regulatory guidance
• Identify regulatory risks and mitigation strategies with partners
• Develop/regulatory strategy changes for PLM/Sustaining activities for US, EU, ROW
• Develop regulatory strategies for Change Controls and ensure regulatory requirements are met
• Support global regulatory strategies by collaborating with international associates
• Lead regulatory efforts to follow EU MDR/IVDR and other standards
• Review and approve product labeling and promotional materials for regulatory compliance
• Coordinate responses to customer information requests and questionnaires
• Ensure FDA listings and facility registrations are maintained
• Develop and maintain SOPs, WIs and policies for compliance
• Represent BD in external trade orgs and support regulatory standards development

Skills

Regulatory affairs experience

Technical writing

Cross-functional collaboration

MS Office proficiency

Education

B.S. in science/engineering/health sciences

Tools

Microsoft Word

Excel

PowerPoint

Job description

BD is seeking a Staff Regulatory Affairs Specialist to drive regulatory leadership for PreAnalytiX and Lab Specimen Management products across US, EU, and other markets. You will guide lifecycle activities, assess regulatory impacts of changes, and help shape strategies for 510(k) and CE marking submissions.

You'll collaborate with R&D, Quality, and Manufacturing, lead regulatory activities in cross-functional teams, ensure compliance with MDR/IVDR, and support international registrations while