Regulatory Affairs Manager – Medical Devices

Job 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.