Regulatory Affairs Associate

1 week ago

Dehra Dun, India Sunfox Technologies private limited Full time

**Job description**

Roles and Responsibilities:

- Reviewing and interpreting regulatory requirements for medical devices and providing guidance to other departments on compliance issues.
- Collaborating with other departments, such as research and development, quality, and manufacturing, to ensure that products meet regulatory requirements.
- Staying up-to-date with changes in regulatory requirements and communicating relevant information to other departments.
- Assessing the regulatory implications of product changes and providing guidance on the approval process.
- Collaborating with external consultants and regulatory bodies to ensure timely clearance or approval of products.
- Maintaining and updating regulatory files, such as Device History Records and Design History Files, to ensure compliance with the latest regulations.
- Communicating with the authorities regarding product compliance and providing responses to their requests for information.
- Participating in internal and external audits to ensure compliance with regulatory requirements.
- Keeping track of the product's regulatory status and ensuring that the products are in compliance with the regulations throughout

Competency Requirements:

- Should have at least 1 year of experience in medical device regulatory affairs handling and documentation.

**Job Types**: Full-time, Internship

**Salary**: ₹176,541.85 - ₹499,985.41 per year

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Dehradun, Uttarakhand: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

**Speak with the employer**
+91 8650035556

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