Swetha Suresh Email & Phone Number

With 7+ years of experience in Medical Device & In Vitro Diagnostics (IVD), I've honed my skills in regulatory affairs, quality compliance, and product life-cycle management. My expertise lies in navigating complex regulatory landscapes (US-FDA, Health Canada, EU-IVDR/MDR, UKCA, CDSCO) and ensuring product compliance.Beyond regulatory excellence, I'm committed to driving business growth through strategic market research and client engagement. I'm keenly interested in identifying untapped market opportunities, developing targeted strategies, building strong relationships with key stakeholders, fostering trust and collaboration, and conducting in-depth market research to understand customer needs and preferences.As a certified Lead Auditor for ISO 13485:2016, I'm passionate about ensuring quality and compliance. My ability to effectively communicate technical information and collaborate across teams has been instrumental in driving continuous improvement initiatives.My passion for innovation, combined with my strong problem-solving and communication skills, makes me a valuable asset to any team.

Listed skills include Leadership, Medical Diagnostics, Clinical Microbiology, Cell Lines, and 32 others.