Head - Remediation - Medical Devices

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.