Quality with Risk Management

Mandatory Skills :- Risk Management. ISO 14971, FDA CFR 820, ISO 13485, Risk Mitigation, Medical Devices.

Location : Bangalore

Notice period : Immediate to 45 days.

Skill Sets

1. 7-12 years working experience in a regulated industry specially as a medical device of relevant experience in medical device risk management.
2. Knowledge in ISO 13485, ISO 14971, FDA CFR 820
3. Medical Device Risk analysis, risk evaluation, risk control, Risk mitigation implementation
4. Good written and verbal communication in English language
5. Strong interpersonal skills
6. Knowledge and understanding of international safety standards for medical devices
7. Related experience with Medical Device Risk analysis and Cybersecurity Risk management

Responsibilities

1. Leads Risk Management efforts, processes and process improvements for assigned product/business portfolio.
2. Knowledge of remediation of risk files as per ISO 14971:2019.
3. Develops and maintains Risk Management Files that include risk management plans, hazard analyses, risk assessments and risk management matrix.
4. Lead issue impacts assessments to calculate risks associated with defects and complaint records.
5. Collaborates as risk management subject matter expert with development teams to ensure the comprehensive implementation of risk control measures are compliant to local requirements as and international standard ISO 14971
6. Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-function teams.

Additional Advantage

Good knowledge of SDLC (IEC-62304) and SaMD.