Quality Assurance and Regulatory Affairs

1 week ago

Bengaluru Karnataka, India LATS Solutions Pvt Ltd. Full time

Position: QARA

Total Exp : 7-10yrs

Budget : 40000 to 60000 INR Fixed

Location : Bangalore

**Skill Sets**
- 7-10 years working experience in a regulated industry specially as a medical device of relevant experience in medical device risk management.
- Knowledge in **ISO 13485, ISO 14971, FDA CFR 820**:

- Medical Device **Risk analysis, risk evaluation, risk control, Risk mitigation implementation**:

- Good written and verbal communication in English language
- Strong interpersonal skills
- Knowledge and understanding of international safety standards for medical devices
- Related experience with Medical Device Risk analysis and Cybersecurity Risk management

**Responsibilities**
- Leads Risk Management efforts, processes and process improvements for assigned product/business portfolio.
- **Knowledge of remediation of risk files as per ISO 14971:2019.**:

- **Develops and maintains Risk Management Files that include risk management plans, hazard analyses, risk assessments and risk management matrix.**:

- Lead issue **impacts assessments to calculate risks associated with defects and complaint records.**:

- Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-function teams.

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

Pay: From ₹480,000.00 per year

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 7 years (required)

Work Location: In person

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