Ipro Networks Pte. Ltd.
Sr. Regulatory Affairs Specialist / Manager -510K Focus
Ipro Networks Pte. Ltd., Sunnyvale, California, United States, 94087
Job Title:
Sr. Regulatory Affairs Specialist / Manager Position Type:
Full-Time, General Recruiting Location:
Sunnyvale, CA or Los Angeles, CA Salary Range:
$80k- $140k base annually on w2 Job ID#:
148164 Summary: 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 submissions to international regulatory authorities. Support government interactions regarding medical device registrations and licensing for Class II and Class III devices. Develop regional regulatory strategies and update strategies 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 for Class I, II, and III devices. Support regulatory activities required for MDR compliance. Conduct regulatory assessments for manufacturing and design changes. Review and approve change order packets. Support product regulatory intelligence and risk assessments. Assist in maintaining compliance with product post-market requirements. Support post-market regulatory actions for the products. Review 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 and records. Other Regulatory and Quality duties as assigned. Requirements: Hands-on experience managing the entire 510(k) submission process for Class II devices is required. Experience with the FDA's Emergency Use Authorization (EUA) is desired. 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. Familiarity with Class I general controls and Class III PMA processes. Demonstrated ability to manage small projects, with exceptional organization, independence, and outcome-driven focus. Outstanding analytical and communication skills, along with a strong sense of teamwork and meticulous attention to detail.
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Sr. Regulatory Affairs Specialist / Manager Position Type:
Full-Time, General Recruiting Location:
Sunnyvale, CA or Los Angeles, CA Salary Range:
$80k- $140k base annually on w2 Job ID#:
148164 Summary: 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 submissions to international regulatory authorities. Support government interactions regarding medical device registrations and licensing for Class II and Class III devices. Develop regional regulatory strategies and update strategies 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 for Class I, II, and III devices. Support regulatory activities required for MDR compliance. Conduct regulatory assessments for manufacturing and design changes. Review and approve change order packets. Support product regulatory intelligence and risk assessments. Assist in maintaining compliance with product post-market requirements. Support post-market regulatory actions for the products. Review 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 and records. Other Regulatory and Quality duties as assigned. Requirements: Hands-on experience managing the entire 510(k) submission process for Class II devices is required. Experience with the FDA's Emergency Use Authorization (EUA) is desired. 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. Familiarity with Class I general controls and Class III PMA processes. Demonstrated ability to manage small projects, with exceptional organization, independence, and outcome-driven focus. Outstanding analytical and communication skills, along with a strong sense of teamwork and meticulous attention to detail.
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