Hello everyone! For the past 3.5 years, I’ve been thriving as a QA/RA Manager in the medical device field, specializing in some key areas that I’m passionate about: • Regulatory approval for innovative in-vitro diagnostic (IVD) software solutions • Leading the end-to-end certification process for medical devices, ensuring smooth compliance from concept to market • Crafting regulatory strategies tailored to complex and diverse markets like the UK, EU, and US • Acting as the primary liaison with major regulatory bodies. One of the things I find most rewarding is mentoring. It’s an incredible way to build strong relationships across different industry levels and give back by sharing tips, insights, and practical know-how. Especially in the highly specialized regulatory affairs community, mentorship creates a unique opportunity to collaborate and uplift each other.
My Mentoring Topics
- - medical device regulatory strategy
- - quality management system (QMS)
- - leadership and team work
- - career opportunity
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