Regulatory Affairs Manager

Regulatory Affairs Manager

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 their 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 labelling, 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.

Requirements:

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.

Nice to Have:

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.