Functional Expertise
- Remediation, New product development, Sustenance Engineering, Regulatory Compliance
Professional Experience Summary
- Brings 8+ years of experience in Medical device domain with specialization in Remediation and Regulatory affairs.
Key Competencies
- Thorough understanding of FDA 21 CFR 820 / ISO 13485 guidelines
- Regulatory compliance documentation
- Orthopedic product design and development / product sustenance experience
- Good understanding and implementation of design controls, change control management, engineering documentation Risk management
- DHF Remediation (Mandatory)
Candidate Qualifications
- BE degree in Mechanical, Embedded or Electrical engineering from a reputed college
- 8+ years of Medical Device experience.
- Ideally with an overall experience of 15+ years.
- Ability to build a team of 100+ associate and managing them would be an added advantage.
Didn’t find the job appropriate? Report this Job