Senior Regulatory Affairs Specialist – Medical Devices

ACON Laboratories; San Diego (CA); In loco; USD 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

ACON Laboratories is seeking a Regulatory Affairs Specialist III in San Diego, CA. The role involves preparing and submitting regulatory documentation for diagnostic products, guiding cross-functional teams, and ensuring compliance with FDA and ISO standards.

The ideal candidate has 5+ years in medical devices/regulatory affairs, with excellent communication and a Bachelor's in a science/engineering field. On-site role in San Diego with potential for regulatory leadership.

Competenze

• Bachelor’s degree in a scientific, engineering, or healthcare-related field.
• 5+ years of regulatory affairs experience in medical devices, in vitro diagnostics, or related industry.
• Strong knowledge of FDA, ISO, and global regulatory requirements.
• Excellent written and verbal communication skills with attention to detail.

Mansioni

• Prepare, review, and maintain regulatory documentation for diagnostic and medical device products.
• Coordinate and submit regulatory filings to global health authorities and support product registrations/approvals.
• Monitor changes in regulatory requirements and advise cross-functional teams accordingly.
• Collaborate with R&D, Quality, Manufacturing, and Marketing to provide regulatory guidance and support audits.
• Manage timelines, regulatory databases, and ensure labeling/promotional materials compliance.

Descrizione del lavoro

ACON Laboratories is seeking a Regulatory Affairs Specialist III in San Diego, CA. The role involves preparing and submitting regulatory documentation for diagnostic products, guiding cross-functional teams, and ensuring compliance with FDA and ISO standards.

The ideal candidate has 5+ years in medical devices/regulatory affairs, with excellent communication and a Bachelor's in a science/engineering field. On-site role in San Diego with potential for regulatory leadership.