
Senior Medical Device Specialist
3 days ago
About the Role:
We are seeking a seasoned professional to lead and grow our Medical Segment in India. The ideal candidate will bring deep domain expertise in medical devices, strong understanding of regulatory frameworks, and proven track record in managing cross-functional teams across product development, compliance, and client engagement.
The successful candidate will drive the vision, roadmap, and execution strategy for the medical segment in alignment with global business goals. This includes leading end-to-end development of medical devices or healthcare solutions, ensuring compliance with ISO 13485, IEC 62304, and FDA regulations.
Key Responsibilities:
- Strategic Leadership: Drive the vision, roadmap, and execution strategy for the medical segment in alignment with global business goals.
- Project & Program Management: Lead end-to-end development of medical devices or healthcare solutions, ensuring compliance with ISO 13485, IEC 62304, and FDA regulations.
- Client Engagement: Act as the primary point of contact for key medical clients, understanding their needs and translating them into actionable engineering and business plans.
- Team Management: Mentor and lead a multidisciplinary team of engineers, regulatory experts, and project managers.
- Innovation & R&D: Collaborate with internal R&D teams to drive innovation in areas such as wearable health tech, diagnostics, imaging, and connected care.
- Regulatory & Quality Compliance: Ensure all products and processes meet global regulatory standards and quality benchmarks.
Required Skills & Experience:
- 10+ years of experience: In the medical device or healthcare technology industry.
- Strong knowledge: Of medical standards (ISO 13485, IEC 60601, IEC 62304, FDA 21 CFR Part 820).
- Experience: In embedded systems, software development, or systems engineering for medical applications.
- Proven leadership: In managing large teams and complex programs.
- Excellent communication: And stakeholder management skills.
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