Senior Regulatory Affairs Specialist

Company: International Erosion Control Association
Location: Thousand Oaks
Posted on: April 15, 2025

Job Description:

Position OverviewA Regulatory Affairs Specialist is needed to support a Class II medical device company currently undergoing clinical trials. This role involves ensuring compliance with applicable regulations, managing regulatory submissions, and supporting clinical trial activities. The ideal candidate will play a key role in navigating regulatory requirements to bring innovative medical devices to market.Key Responsibilities

• Prepare and submit Investigational Device Exemptions (IDEs), 510(k) premarket notifications, and other regulatory filings for FDA and international agencies.
• Ensure compliance with FDA guidelines, Recognized Consensus Standards, and special controls for Class II medical devices
• Assist in internal and external audits, including EU MDR, MDSAP, ISO 13485, and country-specific inspections.
• Maintain regulatory files and manage renewals, updates, and registration
• Assist in preparing ethics review board applications for investigational device trials
• Monitor ongoing clinical trials for compliance with approved protocols and regulatory requirements
• Collaborate with cross-functional teams to gather necessary documentation for submissions
• Respond to regulatory agency inquiries promptly and accurately
• Monitor device-related incidents, complaints, and adverse events for reporting to regulatory authorities
• Support post-market activities such as recalls or field actions if required
• Review product labels and promotional materials for compliance with applicable regulations
• Develop strategies for obtaining timely approvals for new products or modifications to existing ones
• Stay updated on evolving regulations and provide guidance on compliance risksQualifications
  • Education: Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degrees preferred
  • Experience: 6+ years in regulatory affairs within the medical device industry, ideally with experience in Class II devices undergoing clinical trials
  • Certifications: Regulatory Affairs Professional Society (RAPS) certifications preferred.Skills:
    • Strong understanding of EU MDR 2017/745, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other international medical device regulations
    • Strong analytical abilities to interpret complex data and regulations
    • Excellent communication skills for effective collaboration across teams and with regulatory bodies
    • Proficiency in technical systems (e.g., MS Office, databases)
    • Proactive and detail-oriented with a focus on ethical integrity.
    • Ability to manage multiple projects and meet tight deadlines.
    • Creative problem-solving skills combined with critical thinking.
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Keywords: International Erosion Control Association, Los Angeles , Senior Regulatory Affairs Specialist, Other , Thousand Oaks, California