Regulatory Affairs Specialist III - No Relocation
Full-time
ACON Laboratories
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
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.
Vacancy posted 4 days ago
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