Job Description
Job Title: Sr. Regulatory Affairs Specialist / Manager
Location: Sunnyvale, CA / Irwindale, CA
Job Type: Full-Time, Onsite
Salary: $80,000 - $140,000 annually
Job ID: #148164
Job Description We are seeking a highly skilled and detail-oriented
Sr. Regulatory Affairs Specialist / Manager to join our regulatory team. This role is critical in ensuring compliance with medical device regulations and the successful market introduction of innovative products. You will work closely with cross-functional teams to maintain ISO 13485 and FDA-compliant Quality Management Systems while providing regulatory expertise throughout the product lifecycle.
Key Responsibilities - Oversee regulatory processes for medical device development and market introduction.
- Collaborate with Quality, Engineering, Product Management, Marketing, and Sales teams to ensure compliance with regulatory requirements.
- Prepare and review regulatory submissions for the US FDA (including 510k and EUA applications) and international regulatory authorities.
- Support government interactions for medical device registration and licensing.
- Develop and update regional regulatory strategies based on changes in regulatory frameworks.
- Provide regulatory assessments for manufacturing and design changes.
- Review and approve change order packets, ensuring regulatory compliance.
- Conduct product regulatory intelligence, risk assessments, and post-market compliance activities.
- Support MDR compliance and post-market regulatory actions for products.
- Review advertising and promotional materials to ensure regulatory accuracy.
- Assist with internal and external audits, maintaining compliance with internal procedures and external regulations.
- Update and maintain quality system procedures and records, including controlled documents.
- Perform other regulatory and quality-related duties as assigned.
Job Requirements - Bachelor’s degree in Science, Engineering, Math, a medical field, or an equivalent educational background focused on technical writing, scientific methodologies, and problem-solving.
- A minimum of 5 years in medical device Regulatory Affairs, with a strong understanding of regulatory frameworks and standards.
- Proven ability to manage small projects with excellent organizational skills and an outcome-driven focus.
- Outstanding analytical and communication skills with meticulous attention to detail.
- Strong teamwork capabilities while demonstrating independence in task management.
- Proficiency in Mandarin and English to collaborate effectively with multilingual teams.
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, or 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,