Medical Domain

**Roles & Responsibilities**:
**Notice Period: 7 to 10 Days**

Working on Risk files like RMP(Risk Management Plan), RMR (Risk Management Report ) from scratch, From medical domain.

Identification of Hazards and estimation of risk for each Hazard for medical devices

Experience in working on Hazard Matrix table.

Familiarity with ISO 13485 Medical Quality Management System and ISO 14971 Application of Risk Management to Medical Devices.

Knowledge on ISO 14001, USFDA 21CFR part 820, IEC 62304 (Samd).

Implementing and verification of risk control measures, Evaluation of Residual risk and RBA

Hands experience in Design Control (Risk management, Design Review, Process Validation) activities for medical devices.

Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development

Experience in Risk files like RMP, PHA,DHM, dFMEA, aFMEA, pFMEA, RBA, RMR

Creation of Risk Management Report and ensure the RM file is complete

Experience in Requirement Traceability Matrix.

**Required Education/Experience**:
Bachelor’s degree, Engineering or Science discipline preferred or equivalent work experience 5+ years of relevant working experience in creating risk management deliverables.

Knowledge of Quality management systems such as risk management, design controls, CAPAs, doc control, etc.

Strong written and oral communications skills and ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers)

**Salary**: ₹500,000.00 - ₹1,200,000.00 per year

Schedule:

- Morning shift

Supplemental pay types:

- Commission pay
- Joining bonus
- Overtime pay
- Performance bonus
- Quarterly bonus
- Yearly bonus

Ability to commute/relocate:

- Mysore, Karnataka: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 3 years (preferred)

**Speak with the employer**

+91-XXXXXXXXXX