Compliance and Audit Executive

4 weeks ago


Amarnath, India Alan Electronic Systems Pvt. Ltd. Full time

**Responsibilities**:
1. Collaborate with various departments to ensure compliance with MDR(India) 2017, MDR(EU) 2017/745, ISO 13485:2016, ISO 9001:2015 and another relevant applicable regulatory requirement as and when enforced / implemented.

2. Preparation and Compilation of Technical documents according to the above said standards.

3. Update and maintain the relevant docs as and when there are product / Standard changes.

4. SOP, Docs, Forms need to be updated / prepared to comply the above said standards.

5. Conduct Internal and external audit to ensure the implementation of applicable standards.

6. Governing the import, manufacture, distribution, and sale of medical devices in India.

7. Adhere to guidelines set by the Central Drugs Standard Control Organization (CDSCO) and secure necessary approvals for the company's medical energy devices.

**Education and Experience**:
1. **Bachelor's degree in a relevant field such as Biomedical Engineering, Engineering in Electronics, Regulatory Affairs, or a related discipline.**

2. Freshers or individuals with up to 2 years of experience in regulatory compliance or medical device industry are welcome to apply.

3. Strong analytical skills and the ability to interpret complex regulatory information.

**Salary**: ₹20,000.00 - ₹40,000.00 per month

**Benefits**:

- Health insurance
- Provident Fund

Schedule:

- Day shift

Supplemental pay types:

- Yearly bonus

Ability to commute/relocate:

- Ambernath, Thane - 421506, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

**Experience**:

- Medical devices: 2 years (preferred)

**Speak with the employer**
+91 9320553971


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