
Senior Medical Devices Strategist
2 weeks ago
We are seeking an accomplished Medical Devices Specialist to lead the development of innovative medical solutions, driving business growth and ensuring compliance with regulatory frameworks.
Job Description:
The ideal candidate will possess deep domain expertise in medical devices, a strong understanding of regulatory requirements, and a proven track record in managing cross-functional teams. Key responsibilities include developing and executing strategies for medical device development, ensuring compliance with ISO 13485, IEC 62304, and FDA regulations.
Required Skills & Qualifications:
- 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.
Benefits:
- Opportunity to drive innovation in medical devices and healthcare solutions.
- Collaborative work environment with multidisciplinary teams.
- Professional growth and development opportunities.
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.
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