Regulatory Affairs Manager

Regulatory Affairs Manager

Location: Southern California, U.S.

Reports to: Head of Quality & Regulatory Affairs

Mission Statement

Founded in 2015 and headquartered in Shenzhen, SiBionics is one of the world’s fastest-growing innovators in continuous glucose monitoring (CGM) and digital health solutions. Our flagship GS1 and GS3 CGM systems are CE-marked under MDR and approved in China, making SiBionics one of the top 3 CGM providers globally by user base.

As we expand into the U.S. market, the Regulatory Affairs Manager will play a pivotal role in shaping the company’s regulatory strategy and ensuring compliance with U.S. FDA and international medical device requirements. This individual will serve as the primary liaison with the FDA and other regulatory authorities, ensuring that all submissions, interactions, and post-market obligations meet the highest standards of accuracy, ethics, and scientific integrity.

Key Responsibilities

• Develop and execute U.S. regulatory strategies to support product submissions (e.g., IDE, 510(k), De Novo) and post-market requirements.
• Serve as the primary point of contact with the U.S. Food and Drug Administration (FDA) and other regulatory agencies, leading meetings, Q-Subs, and communications.
• Collaborate with cross-functional teams (R&D, Clinical, QA, Manufacturing) to align regulatory strategies with product design, testing, and commercialization plans.
• Prepare, review, and manage regulatory submissions, technical files, and design dossiers for U.S. and global markets.
• Interpret and communicate regulatory requirements, guidance, and changes (e.g., 21 CFR Parts 807, 812, 814, 820; ISO 13485; ISO 14971; MDR).
• Ensure labeling, advertising, and promotional materials comply with FDA regulations and company policies.
• Support quality and clinical teams in pre-submission meetings, audits, and inspections.
• Monitor evolving U.S. and international regulatory landscapes, providing proactive recommendations to management.
• Develop and maintain relationships with regulatory consultants, testing labs, and external partners.
• Provide regulatory training and mentoring to internal stakeholders.

Desired Qualifications

Required:

• Bachelor’s degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field (Master’s preferred).
• Minimum of 8 years of regulatory affairs experience in the medical device industry (preferably Class II/III).
• Demonstrated experience with FDA submissions (510(k), IDE, or PMA) and direct interaction with FDA reviewers.
• Solid understanding of U.S. FDA regulations, QSR (21 CFR Part 820), ISO 13485, ISO 14971, and related standards.
• Excellent written and verbal communication skills in English, with the ability to represent the company professionally before regulatory bodies.

Preferred:

• Experience with software-enabled or wearable medical devices.
• Knowledge of EU MDR and international submissions (e.g., Canada, Australia, Japan).
• RAC (U.S.) certification or equivalent professional credential.
• Bilingual (English and Mandarin) a plus but not required.
• Strong problem-solving, strategic thinking, and organizational skills suitable for a fast-paced startup environment.

Compensation & Benefits

• Salary Range: $110,000 – $145,000 per year (based on experience)
• 401(k) plan, medical, dental, and vision insurance
• PTO and paid holidays
• Opportunity to join a rapidly expanding international medical device company at an early stage of its U.S. strategy
• High exposure to FDA regulatory interactions and global commercialization strategy

Job Type: Full-time

Pay: $110,000.00 - $140,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance

Work Location: In person

Salary : $110,000 - $145,000