Regulatory Affairs Project Manager
: Job Details :

REGULATORY AFFAIRS PROJECT MANAGER

About MicroPort®:

As an innovative high-end medical device group, MicroPort® was founded in 1998 in ZJ Hi-Tech Park in Shanghai, China. It has 400+ products on the market and more than 6,800 patents (including patent applications) and 25 products entitled to the national green channel for expedited registration for innovative medical devices. MicroPort® employs nearly 10,000 employees from more than 30 countries, of whom more than 50% are Chinese. Our extensive business covers 12 major medical device fields. We continually strive to help create a better world through providing enabling technologies to support the wellbeing of our patients, every 6 seconds we made a difference.

About the Role

MicroPort Scientific America is seeking a highly experienced and credentialed Project Manager, Vertical Marketing and Regulatory Affairs, to lead and execute regulatory and go-to-market strategy on high profile projects across our medical device portfolio. Reporting to the Chief Medical Officer and based in our Irvine, CA office, this role will manage regulatory compliance processes, direct submissions to global health authorities, clinical trial support, market development, go-to-market and oversee day-to-day project operations. This is a first-level management role with direct responsibility for guiding team members across the globe and driving cross-functional alignment to meet regulatory and business goals within the US market.

Key Responsibilities

• Manage regulatory affairs for assigned programs, ensuring compliance with applicable global regulations, including FDA (510(k), PMA, IDE, De Novo), ISO, and other regional standards.
• Execute and oversee regulatory strategies to support product development, market entry, and lifecycle management.
• Implement and maintain systems to track and ensure timely licensing, filings, certifications, and permits.
• Lead preparation and submission of regulatory documentation to domestic and international authorities.
• Utilize monitoring tools and procedures to ensure continued compliance and proactively identify regulatory risks.
• Anticipate new or evolving regulatory requirements and coordinate internal response strategies with clinical, R&D, quality, and manufacturing stakeholders.
• Investigate and address issues of non-compliance; prepare for and participate in audits or inspections.
• Manage departmental milestones, timelines, and budgets; contribute to resource planning and process improvement.

Qualifications

• Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field (Master's or PhD preferred).
• Minimum 5-8 years of experience in regulatory affairs and vertical market management within the medical device industry (Class II and/or III).
• 1–3 years of supervisory or managerial experience preferred.
• Deep understanding of U.S. FDA regulations, submission processes, and quality system standards.
• Experience with global regulatory filings (e.g., CE Mark, NMPA) is a strong plus.
• Demonstrated ability to lead cross-functional projects and manage multiple priorities.
• Strong written and verbal communication skills; experience interfacing with regulatory bodies and executive leadership.
• RAC certification a plus.

What We're Looking For

• A proactive, detail-oriented leader who combines strategic insight with executional rigor.
• A team builder and communicator who can align stakeholders across functions and levels.
• A compliance-driven problem solver who thrives in a dynamic, innovation-focused environment.

Note: This job description is intended to provide a general overview of the position. It is not an exhaustive list of all responsibilities, skills, duties or requirements associated with the job.

Perks:

Our company offers excellent benefits including competitive medical, dental, and vision insurance coverages, as well as individual supplemental insurance options. We offer a 401K plan with employer matching, paid holidays and a PTO policy.

To learn more, please visit our website:

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MicroPort and its subsidiaries are proud to provide equal-opportunity employment to all employees and applicants, without regard to race, creed, color, religion, national origin, citizenship, ancestry, age, veteran status, disability, pregnancy, marital status, genetic information, or any other categories protected by federal, state, or local law. As per company policy, official hiring will be pending the results of a background check and drug test.