Head - Remediation & Regulatory Affairs - Medical Devices Business

Our Client is a highly visible name and a fast-growing organization in the Engineering Services Space. They have rapidly established a strong customer spread across Aerospace, Defense, Auto, Heavy Engineering and now in Medical Device sectors.

As a part of their newly setup Medical Devices Business, we are looking for a Head of Remediation and Regulatory Affairs

Work Location: Hyderabad

Value Proposition: Setup the Remediation and Regulatory Affairs involving New Product Development, Sustenance Engineering, and Regulatory Compliance.

Major roles and responsibilities would be

- Carry out DHF remediation activities as per approved remediation plan.

- Effective implementation and monitoring of risk management and risk analysis activities (FMEA) according to ISO 14971

- Develop protocols and procedures.

- Technical writing - reports and technical justification.

- Develop understanding in functional / system testing of medical devices.

- Involved in investigating the root cause of product complaint, product non conformance or process deviation and taking appropriate corrective/preventive actions

We are looking for a candidate whose profile would be as under

- BE degree in Mechanical /Electrical / Electronics engineering from a reputed college having an overall 15 years of experience of which atleast he/she has 8 years of experience in the Medical Devices domain with specialization in Remediation and Regulatory Affairs

- Ability to build a team of 100+ associate and managing them would be an added advantage.

- 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)

- Strong Medical Devices domain competency in at least two of the following areas: Diabetes, Cardiovascular, Remote Monitoring, Therapeutic, Radiology, Hospital equipment, Bed Side equipment or Orthopedics.

Please feel free to call me (Balasubramaniam or Bala) on +917899356444 for any further queries. This is only for those in the field of Medical Devices.