Job Description

Sr. Regulatory Affairs Specialist
Locations: Sunnyvale, CA               Job Type:  On-site, FTE
Salary Range: 80K-140K

Responsibilities:

• In this role, you will be part of the regulatory team responsible for proper oversight of medical device development and market introduction.
• 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 and international (outside the US) regulatory authorities.
• Support government interactions pertaining to medical device registrations and licensing;
• Participate in the development of regional regulatory strategy and update strategy based on regulatory changes.
• FDA 510k and EUA application
• Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle.
• 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.
• 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.

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 more about our commitment to diversity and inclusivity at

Compensation: The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, IntelliPro provides a comprehensive benefits package, all subject to eligibility

 

Job Tags

Full time, Work experience placement,

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