Senior RAQA Manager (Medical Device)

Healthcare · Healthcare

Job Description

Provide regional leadership across Regulatory Affairs and Quality Assurance, ensuring products and business activities comply with applicable regulatory and quality requirements across ASEAN markets.
Oversee product registration, regulatory submissions, renewals, variations, post-market requirements and other lifecycle activities.
Provide regulatory and quality guidance to country teams, commercial teams and partners.
Business Unit Growth: Build, launch, and scale the commercial strategy to sell our regional regulatory capabilities as a standalone service to global medical technology principals.
Revenue Generation: Serve as the primary technical point of contact to pitch, onboard, and retain third-party medical device clients navigating complex ASEAN regulatory entry.
Lead the development and expansion of the company's own house range of products, identifying product categories with strong market potential and strategic relevance.
Build a structured portfolio strategy covering product selection, positioning, pricing, market potential and country applicability.

Experience: 8–10+ years of progressive leadership experience in Regulatory Affairs, Quality Assurance, or Commercial Supply Chain Operations within the MedTech, Medical Device, or Healthcare Sourcing
Regulatory Expertise: Proven track record of successfully managing multi-country medical device registrations (GDPMD, ISO 13485) and dealing with regional regulatory authorities (e.g., MDA, HSA).
Experience working with medical consumables and/or OEM manufacturers.
Strong commercial acumen and the ability to translate technical and regulatory capabilities into marketable business propositions.
Mindset: An entrepreneurial "business-builder" mindset with the commercial polish required to pitch services directly to senior executive principals.
Education: Bachelor’s degree in Biomedical Science, Pharmacy, Supply Chain Management, or a related discipline. An advanced degree or professional regulatory certification is highly advantageous.

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Multinational Company