Regulatory Affairs Specialist

Regulatory Affairs Specialist - Medical Devices (PMA Experience)

Location: Irvine, CA
Reports To: Regulatory Affairs Manager

Job Summary:

We are seeking a Regulatory Affairs Specialist with expertise in Pre-Market Approval (PMA) processes to join our team. This role is responsible for ensuring compliance with FDA regulations and other global regulatory requirements for medical devices. The ideal candidate will have experience preparing and submitting regulatory applications, managing documentation, and collaborating with cross-functional teams to support product development and commercialization.

Key Responsibilities:

• Prepare and submit PMA applications, 510(k) submissions, and other regulatory filings.
• Develop and implement regulatory strategies to ensure compliance with FDA, EU MDR, and other international regulations.
• Maintain regulatory documentation, including technical files, design dossiers, and risk assessments.
• Collaborate with R&D, Quality Assurance, and Clinical Affairs teams to support product development and regulatory approvals.
• Monitor and interpret changes in regulatory requirements, providing guidance to internal teams.
• Communicate with regulatory agencies, responding to inquiries and ensuring timely approvals.
• Assist in post-market surveillance activities, including adverse event reporting and compliance audits.
• Support labeling and promotional material reviews to ensure regulatory compliance.

Qualifications & Skills:

• Bachelor's degree in Biomedical Engineering, Regulatory Affairs, Life Sciences, or related field.
• 3+ years of experience in regulatory affairs within the medical device industry.
• Proven experience with PMA submissions and regulatory pathways.
• Strong knowledge of FDA regulations
• Excellent technical writing and communication skills.
• Ability to manage multiple projects and deadlines effectively.

For this position you must be currently authorized to work in the United States. We do not sponsor for this position.