Regulatory Affairs Specialist - Intellectt INC

Job Title: Regulatory Affairs Specialist

Location: Irvine, CA

Duration: 12 months

Support and maintain regulatory approvals for medical devices, ensuring compliance with global regulations.

Key Responsibilities:

• Collaborate with product development and manufacturing teams to provide regulatory guidance, resolve conflicts, and meet requirements.
• Prepare and manage submission documentation for global regulatory agencies and track milestones.
• Interact with regulatory bodies like the FDA, EU notified bodies, Japan PMDA, and others during submissions or audits.
• Advise on regulatory requirements and contingency planning.
• Monitor and assess global regulations, providing insights to expedite approval processes.
• Review labeling, product changes, and documentation to ensure regulatory compliance.
• Prepare and submit documents to international regulatory bodies.

Experience & Skills Required:

• Experience with EU MDR and global regulatory bodies.
• Knowledge of Microsoft Office, Adobe, and product lifecycle management systems (Agile, Teamcenter).
• Experience with class II & III medical devices, product registration, license renewals, and FDA/EU audits.
• Manufacturing experience, especially OUS transfer solutions and compliance initiatives.

Education & Experience:

• Bachelor's degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry).
• 2-4 years of experience in regulatory affairs, preferably in medical devices.

Additional Details:

• Standard office hours, 5 days a week on-site.
• No travel involved.
• Experience with Ignite PLM (Teamcenter) and labeling software is preferred.