Meril Hiring for Executive / Asst. Manager – Risk Management at Pardi, Gujarat, India Full Time

You will be responsible for the following:

• Execute & Support Product Risk Analysis, Evaluation & Control for Cardiovascular products in accordance to ISO14971:2019 with very minimal supervision.
• Responsible for identifying risks and helping define requirements and verification & validation testing to mitigate risk.
• Working Knowledge on Various Risk Analysis techniques like FTA, FMEA, Hazard Analysis as applicable to Medical Devices.
• Collaborate with cross functional teams like Production, QA, QC, Clinical for the development of design FMEA, Process FMEAs, User/Application FMEAs and roll-up into Risk Management files.
• Creates Design History File deliverables associated with Risk Management File like RM Plan, RM Report, and Risk-Benefit Analysis.
• Involve in Production and Post-Production Information as part of Post Market Surveillance System.
• Support product risk management related audits (internal and external).

Requirements

You will need the following to be successful in this role:

• 3-5 years of experience in risk management domain in the medical device industry.
• Has successfully applied the Risk Management activities in at least one significant project.
• Working knowledge of FMEAs is Mandatory.
• Hands on experience on interpreting ISO 14971and applying it to Risk management.
• Knowledge of standards like ISO 13485, IEC 62366.
• Knowledge of Medical Device regulations (FDA 21CFR820, EU MDR)
• Knowledge on regulatory pathways like FDA’s 510(K) & PMA.
• Regulatory bodies audit experience.
• Passion for Risk Management in Medical Devices and zeal to grow as Risk Specialist for Cardiovascular portfolio.
• Excellent communications skills to interface with cross functional teams.
• Good Technical Writing skills as applicable to Risk Management activities like drafting RM Plan, Report. etc.

Having The Below Is a Bonus:

• Applied Risk Management as per ISO 14971 to Medical Devices which were being introduced in US Market but existed in EU Market historically.
• Worked on Medical Device introduced in US market through PMA route.
• Provided actionable insights/suggestions to project teams based on Risk Analysis.
• Knowledge on Cardiovascular or Structural Heart Devices.
• Ready to join either immediately or on short notice.

Benefits

Immediate Joiners preferred (max. allowed notice period is 30 days)

Requirements

You will need the following to be successful in this role: 3-5 years of experience in risk management domain in the medical device industry. Has successfully applied the Risk Management activities in at least one significant project. Working knowledge of FMEAs is Mandatory. Hands on experience on interpreting ISO 14971and applying it to Risk management. Knowledge of standards like ISO 13485, IEC 62366. Knowledge of Medical Device regulations (FDA 21CFR820, EU MDR) Knowledge on regulatory pathways like FDA’s 510(K) & PMA. Regulatory bodies audit experience. Passion for Risk Management in Medical Devices and zeal to grow as Risk Specialist for Cardiovascular portfolio. Excellent communications skills to interface with cross functional teams. Good Technical Writing skills as applicable to Risk Management activities like drafting RM Plan, Report. etc. Having the below is a Bonus: Applied Risk Management as per ISO 14971 to Medical Devices which were being introduced in US Market but existed in EU Market historically. Worked on Medical Device introduced in US market through PMA route. Provided actionable insights/suggestions to project teams based on Risk Analysis. Knowledge on Cardiovascular or Structural Heart Devices. Ready to join either immediately or on short notice.