Sr. Regulatory Affairs Specialist / Manager - Ipro Networks Pte. : Job Details

Job Title: Sr. Regulatory Affairs Specialist / ManagerPosition Type: Full-Time, General RecruitingLocation: Sunnyvale, CA or Los Angeles, CASalary Range: $80k- $140k base annually on w2Job ID#: 148164Summary:The Sr. Regulatory Affairs Specialist/Manager will oversee medical device development and market introduction, ensuring compliance with regulatory standards for Class I, II, and III devices. This role involves collaborating with cross-functional teams to conduct regulatory pre- and post-market analyses, preparing submissions for FDA 510(k) and EUA applications, and maintaining an ISO 13485-compliant Quality Management System. Strong analytical, communication, and project management skills are essential for success in this role.Responsibilities:

• Oversee medical device development and market introduction, including Class I, Class II, and Class III devices.
• Collaborate with Quality, Engineering, Product Management, Marketing, and Sales teams to perform regulatory pre- and post-market analysis and maintain an ISO 13485 and FDA-compliant Quality Management System.
• Prepare and review regulatory submissions to the US FDA, including 510(k) and EUA applications, and international regulatory authorities.
• Support government interactions for medical device registrations and licensing for Class II and Class III devices.
• Develop regional regulatory strategies and update based on regulatory changes.
• Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle.
• Ensure compliance with FDA and global regulatory requirements, including general and special controls for Class I and Class II devices, and premarket approval (PMA) for Class III devices.
• Support regulatory activities required for MDR compliance.
• Conduct regulatory assessment for manufacturing and design changes.
• Review and approve change order packets.
• Support product regulatory intelligence and risk assessments.
• Maintain compliance with product post-market requirements.
• Assist in the review of advertising and promotional materials.
• Support internal and external audits.
• Ensure compliance with internal procedures and external regulations and standards.
• Maintain and update quality system procedures.
• Maintain quality records and other controlled documents.
• Other Regulatory and Quality duties as assigned.Requirements:
  • Bachelor's degree in Science, Engineering, Math, a medical field, or equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving.
  • A minimum of 5 years of experience in medical device Regulatory Affairs, showcasing a comprehensive understanding of regulatory frameworks.
  • Experience with Class II devices subject to 510(k) submission and FDA's EUA processes, as well as familiarity with Class I general controls and Class III PMA processes.
  • Demonstrated ability to manage small projects, displaying exceptional organization, independence, and outcome-driven focus.
  • Outstanding analytical and communication skills, paired with a strong sense of teamwork and meticulous attention to detail.
  • Ability to independently manage 510(k) submissions. #J-18808-Ljbffr