Specialist

Experience:

Location:

Industry:

Job Summary:

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, a strong understanding of regulatory frameworks, and a proven track record in managing cross-functional teams across product development, compliance, and client engagement.

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.

Preferred Qualifications:

• Bachelor’s or Master’s degree in Biomedical Engineering, Electronics, or related field.
• PMP or equivalent project management certification.
• Exposure to AI/ML in healthcare or digital health platforms is a plus.