Senior Regulatory Affairs Specialist – International (China Market)
Location: Sylmar, California, United States
Employment Type: Full-Time
Category: Regulatory Affairs – Medical Devices
Experience Required: 7+ Years
Primary Regulatory Focus: China (NMPA)
About Abbott
Abbott is a globally recognized healthcare leader committed to improving lives at every stage. With a workforce of more than 114,000 professionals across 160+ countries, Abbott delivers innovative healthcare solutions spanning diagnostics, medical devices, nutrition, and branded generic medicines. The company is consistently ranked among Fortune’s most admired companies and is recognized worldwide for its inclusive, high-performance work culture.
Abbott’s medical device portfolio includes advanced technologies that are faster, safer, and less invasive, enabling better outcomes in areas such as cardiac rhythm management, diabetes care, chronic pain, and movement disorders. Abbott’s innovations help hundreds of thousands of patients worldwide live healthier and more independent lives.
Position Overview
Abbott is seeking a Senior Regulatory Affairs Specialist – International (China) to join its Regulatory Affairs team at its Sylmar, California facility. This role is responsible for leading and managing regulatory submissions and approvals with China’s National Medical Products Administration (NMPA) for Abbott’s Cardiac Rhythm Management medical devices.
The position requires close collaboration with regulatory teams in China and the United States, acting as a key liaison between global stakeholders. The successful candidate will be a subject matter expert in international regulatory affairs, providing strategic guidance throughout the full product lifecycle.
Key Responsibilities
Lead and manage China NMPA regulatory submissions, including registrations, progress reports, supplements, and amendments.
Serve as a senior regulatory expert within the organization, providing strategic direction on international regulatory pathways.
Act as the primary regulatory liaison between U.S.-based teams, China regulatory counterparts, and external regulatory authorities.
Interact directly with regulatory agencies to facilitate and expedite approvals of pending registrations.
Support product development, risk management, and regulatory strategy planning throughout the product lifecycle.
Ensure timely approvals for new medical devices, combination products, and continued compliance for marketed products.
Represent Regulatory Affairs on cross-functional product development core teams.
Advise research, development, manufacturing, and marketing teams on regulatory requirements, labeling, manufacturing changes, and line extensions.
Contribute to process improvements related to regulatory strategy, documentation, and submission management.
Education & Experience Requirements
Associate Degree or higher in a scientific, engineering, or healthcare-related discipline.
Minimum 7 years of experience in Regulatory Affairs within the medical device industry.
Proven experience managing international regulatory submissions and agency interactions.
Strong understanding of global medical device regulations and compliance frameworks.
Preferred Qualifications
Bachelor’s Degree or equivalent combination of education and professional experience.
Fluency in Mandarin (written and spoken) is strongly preferred.
Hands-on experience with NMPA submissions for medical devices.
Prior experience in regulatory compliance, R&D, and/or quality within the medical device industry.
Solid knowledge of product development processes, quality management systems, biocompatibility, software, and cybersecurity regulations.
Minimum 3 years of regulatory submissions experience; 4+ years of direct regulatory submissions experience is preferred.
Proficiency with EDMS, regulatory publishing tools, registration management systems, and Adobe Acrobat or equivalent platforms.
Ability to rapidly learn new technologies and adapt to evolving regulatory requirements.
Excellent written and verbal communication skills with strong cross-functional collaboration ability.
Compensation & Benefits
Base salary range: USD 86,700 – 173,300 (may vary by location and experience).
Comprehensive health insurance, retirement plans with employer contributions, and wellness programs.
Tuition reimbursement, student loan support programs, and professional development opportunities.
Career growth within a globally respected and innovation-driven healthcare organization.
Equal Opportunity Employer
Abbott is an Equal Opportunity Employer committed to diversity, equity, and inclusion. All qualified applicants will be considered without regard to protected characteristics.
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