Senior Director, Global Commercial Quality
About the Role
We have been retained by a fast-growing global medical device group to lead the search for a senior commercial quality executive to shape its international post-market and commercial quality function. Our client operates across the US, Europe, and Asia-Pacific, and is building out senior leadership to own the quality experience once products reach the market — complaint handling, vigilance, and post-market surveillance across its international subsidiaries.
This is a newly elevated, high-visibility mandate reporting into senior quality leadership at our client, with the opportunity to build and shape the commercial quality function as the business scales internationally.
Key Responsibilities
- Build and lead the global commercial quality function, owning the quality experience across international markets once products reach the market
- Design and stand up global complaint handling infrastructure and networks to support international business growth and new market launches
- Own post-market surveillance globally — complaint investigations, trend analysis, and database/systems management across international subsidiaries
- Make and escalate safety and vigilance decisions on a global scale during the post-market phase, in line with regional regulatory expectations
- Lead field corrective actions and post-market CAPA, ensuring compliance with local regulatory requirements in each market
- Set commercial quality strategy and standards across international subsidiaries, aligning local execution with global policy
- Partner with regulatory affairs and commercial teams to support new market entry from a quality and post-market compliance standpoint
- Lead audits related to post-market and commercial quality processes across international entities, ensuring consistent standards globally
What We're Looking For
- Significant experience in commercial/post-market quality leadership within the medical device industry, with exposure to multiple regulatory regions (e.g., US, EU, APAC)
- Strong working knowledge of post-market surveillance, vigilance, and complaint-handling requirements under frameworks such as ISO 13485, FDA QSR (21 CFR 820), and EU MDR
- Track record of building or scaling global/regional complaint handling or vigilance networks
- Experience supporting international market entry from a post-market/commercial quality standpoint is a strong plus
- Demonstrated ability to lead across cultures and geographies, working effectively with cross-border teams and stakeholders
- Working proficiency in English is required. Proficiency in an Asian language strongly preferred — Chinese, Japanese, or Korean
- Willingness to travel extensively and thrive in a fast-paced environment
- Strategic mindset paired with a hands-on, roll-up-your-sleeves approach
Why This Role
- Strong growth trajectory, with continued investment in expanding the product portfolio and international presence
- Quality is treated as a strategic differentiator rather than a back-office compliance function, giving this role genuine influence with senior leadership and external stakeholders
- A rare opportunity to build and elevate the global commercial quality function at a company already operating at international scale, with high visibility to senior leadership
精选福利
Medical insurance, Vision insurance, Dental insurance, 401(k), Pension plan