Regulatory Affairs Executive

2 weeks ago

Shivaji Nagar Pune Maharashtra, India NextUP Pharma Full time

**Job description**

1. Responsible for all medical device registration submission under in India and Indian subcontinent countries as required. Ensure medical devices in the designated geographies obtained approval status before commercialization.
2. Maintain the device registration status and ensure timely re-registration.
3. Provide support the local distributors in India subcontinent countries to register devices when required.
4. Provide guidance and advice in Legal and Regulatory requirements including mandatory label marking requirements.
5. Responsible to review and approve the relevant artwork, package label and marketing materials from regulatory and customs aspects covering inhouse and outsourced product portfolio.
6. Ensures labels for India meet Package Commonality Rules and Customs requirements.
7. Evaluates, reviews and approves product claims on labels and marketing collaterals in accordance to legal and regulatory requirements.
8. Maintains label marking and guidance templates for MED and PPE/ SU products.
9. Provides professional advice, propose feasible solutions and supports local cross
- functional teams in business decision making process.
10. Identify strategy for change management to product and business. Establish plan to ensure effective implementation. Consults the respective governmental agencies on regulatory requirements for new products and major changes in existing products.

**Salary**: ₹12,838.63 - ₹45,075.42 per month

**Benefits**:

- Internet reimbursement

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Shivaji Nagar, Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 1 year (preferred)

**Speak with the employer**

+91 9762972000

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