Regulatory Affairs Specialist III - No Relocation

ACON Laboratories; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Job description

Company Description

ACON Laboratories is an international diagnostic and medical device company with corporate headquarters in San Diego, California. For more than 15 years, the organization has focused on providing high-quality, affordable diagnostic solutions to people in over 130 countries. The U.S. office serves as the hub for strategic management, administration, business development, and innovative research and development. ACON’s state-of-the‑art manufacturing facility is ISO 13485:2003 certified, FDA registered, and has been inspected by the U.S. FDA. Current product lines span Diabetes Care, Clinical Chemistry, and Immunoassay, with additional products in development.

Role Description

The Regulatory Affairs Specialist III role is a full-time, on‑site position based in San Diego, CA. This role is responsible for preparing, reviewing, and maintaining regulatory documentation for diagnostic and medical device products, ensuring accuracy and completeness. The specialist will coordinate and submit regulatory filings to global health authorities, support product registrations and approvals, and monitor changes in regulatory requirements. Day‑to‑day activities include collaborating with cross‑functional teams (R&D, Quality, Manufacturing, and Marketing) to provide regulatory guidance, supporting audits and inspections, and contributing to regulatory strategies for new and existing products. The role also involves managing timelines for submissions, maintaining regulatory databases, and assisting in the development and review of labeling and promotional materials for compliance.

Qualifications

• Strong proficiency in Regulatory Affairs and understanding of global Regulatory Requirements.
• Experience with Regulatory Documentation and Regulatory Submissions for medical devices or diagnostics.
• Demonstrated ability to ensure Regulatory Compliance with FDA, ISO, and other relevant standards.
• Bachelor’s degree in a scientific, engineering, or healthcare‑related field; advanced degree or regulatory certification (e.g., RAC) preferred.
• 5+ years of regulatory affairs experience in medical devices, in vitro diagnostics, or related industry, including direct interaction with regulatory agencies.
• Solid knowledge of quality systems, product development processes, and risk management principles.
• Excellent written and verbal communication skills, with attention to detail and strong organizational abilities.
• Proven ability to work collaboratively in cross‑functional teams, manage multiple projects, and meet deadlines in a fast‑paced environment.