Regulatory Affairs Manager

Regulatory Affairs Manager - Medical DevicesJob Responsibilities:Lead regulatory strategy and submissions for medical device products, including FDA 510(k), Q-subs, and international market approvals.Oversee regulatory compliance for ISO 13485, FDA, MDR/IVDR, and other applicable standards.Collaborate cross-functionally with Quality, Engineering, and Product teams throughout the product lifecycle.Manage government interactions, regulatory impact assessments, and post-market requirements.Support audits, advertising reviews, and risk assessments.Establish and lead a high-performing Regulatory Affairs team.Qualifications:Master's degree in Life Sciences, Engineering, or a related field.5+ years of Regulatory Affairs experience in the medical device industry, with expertise in US, EU, and international regulations.Proven track record in regulatory submissions and negotiations with global regulators.Strong analytical, organizational, and communication skills.Managerial experience in a regulated industry is required.Fluency in English and Mandarin is a must. This role offers the opportunity to make a significant impact on regulatory strategy and product compliance in a fast-paced, innovative environment.

Created: 2025-01-25