Regulatory Affairs Specialist

Regulatory Affairs Specialist

Location: Brea, CA (On-site 4 days/week) 1 day from home (DEPARTMENT RELOCATING TO CHINO AT THE END OF THE YEAR)

Contract Duration: 2-year project contract

Rate: $35.00/hr

Position Overview:

We are seeking a Regulatory Affairs Specialist contractor to join our team for a two-year project. This role will focus on global regulatory activities, including product registration submissions, facility registrations, and supporting regulatory strategy to drive market growth worldwide. The Specialist will collaborate with cross-functional teams to ensure compliance with country-specific requirements throughout product development, launch, and post-market activities.

Primary Duties & Responsibilities:

• Stay current with regulations, including proposed and final rules from regulatory authorities, and provide regulatory support as needed.
• Create and maintain procedures, SOPs, and technical documentation to support regulatory operations.
• Assist in drafting Technical Files and compiling documentation for global product registrations.
• Implement and coordinate regulatory strategies in alignment with senior leadership.
• Prepare and maintain regulatory submissions, product registrations, certifications, and facility registrations, ensuring compliance with regional requirements.
• Work directly with distributors, in-country consultants, inter-company partners, and commercial teams to meet regulatory requirements.
• Review product, manufacturing, and labeling changes for regulatory compliance and reporting impact.
• Serve as a strategic partner in navigating complex compliance landscapes and ensuring timely product registrations.

Qualifications:

• Bachelor’s degree (BA/BS) from a four-year college/university.
• 1+ years of experience in medical devices and/or training in an FDA-regulated industry.
• Strong attention to detail, sense of urgency, and ability to prioritize multiple projects.
• Respectful, open-minded, and willing to take calculated risks to challenge the status quo.
• Accountable for work outcomes and proactive in driving positive results.
• Team player with excellent communication skills and a “can do” attitude.

Apply today and help drive the mission. Send your resume to View email address on click.appcast.io Or call Daisy at View phone number on click.appcast.io