Ipro Networks Pte. Ltd.
Sr. Regulatory Affairs Specialist / Manager
Ipro Networks Pte. Ltd., Los Angeles, California, United States, 90079
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 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.
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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 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.
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