Job Description

Job Title: Sr. Regulatory Affairs Specialist / Manager

Position Type: Full-Time, General Recruiting

Location: Sunnyvale, California

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. The specialist will also support government interactions regarding device registrations, manage regulatory assessments for product changes, and ensure compliance with global regulatory requirements throughout the product lifecycle. Strong analytical, communication, and project management skills are essential for success in this role.

• In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction, including Class I, Class II, and Class III devices.
• You will work closely with Quality, Engineering, Product Management, Marketing, and Sales teams to perform regulatory pre- and post-market analysis and implement and maintain an ISO 13485 and FDA-compliant Quality Management System.
• Participate in the preparation and review of regulatory submissions to the US FDA, including 510(k) and EUA applications, and international (outside the US) regulatory authorities.
• Support government interactions pertaining to medical device registrations and licensing for Class II devices (e.g., blood pressure monitors, and glucose meters) and Class III devices (e.g., pacemakers, and heart valves).
• Participate in the development of 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, including the 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.
• Provide regulatory assessment for manufacturing and design changes.
• Provide regulatory review and approval of change order packets.
• Support product regulatory intelligence and risk assessments.
• Assist in maintaining compliance with product post-market requirements.
• Support post-market regulatory actions taken for the products.
• 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 an 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 working 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.

About Us:

Founded in 2009, IntelliPro stands as a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. With a dynamic presence in the USA, China, Canada, Singapore, Philippines, UK, India, Netherlands, and Germany, we continue to lead the way in global talent solutions.

IntelliPro, a global leader in connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn moreabout our commitment to diversity and inclusivity at

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