Vacancy for Regulatory Affairs at Delhi Ncr

2 weeks ago

Mumbai, India RIGHT STAFF Full time

Greetings from Right Staff

One of our client who are into Medical Devices

Are looking for a Regulatory Affairs person at Delhi NCR

Job Description
- Designation - Regulatory Affairs/QA Affairs

Time - Day Shift

Location - Delhi NCR

**Responsibilities**:

- 1. Identify regulatory and post market requirements for new products or product enhancements early in the product development cycle. Collect and implement regulatory and post market requirements.

2. Gather information to support regulatory submission and related compliance activities. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims. Coordinate compulsory test in the region when there is the need.

3. Review product revision requests to assure compliance with regulatory and post market requirements. Assess new product launch requirements and provide the regulatory information according to the needs.

4. Work on product teams to develop regulatory strategy based on regulatory and post market requirements.

5. Review and approve labelling and marketing literature, as needed.

6. Support RAQA management and other Regulatory Affairs staff with all regulatory and compliance matters. Conduct timely activities of supervisor assigned.

7. Work with direct supervisor and senior internal stakeholders to identify key initiatives, which may be affected by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management.

8. Conduct and ensure timely reporting of recall and/or Adverse Event. Work with Compliance team and follow the regulation for Recall and Adverse Event reporting.

9. Archive and maintain all paper and electronic submission documents properly.

10. Protect company confidential information by properly storing, retrieving, and disseminating such information only to those authorised.

12. Work with RAQA management and cross-functionally with local team to assure the ISO 13485 and/or other quality system standard to be operated in compliance with applicable regulatory standards, including participation in internal and external audits / inspections as well as supplier audits / inspections.

13. Development / maintenance of local quality system processes, ISO 13485 and/or customer audit facilitation and document control.

14. Utilise CAPA (Corrective Action / Preventative Action) system, including issuance of CAPAs, tracking of open CAPAs, and reporting on CAPA effectiveness.

15. Local labelling management and change control to ensure compliance with labelling requirements.

16. Gather and trend quality data for Quality Management Reviews.

17. Supplier management including supplier evaluation, audit, maintenance of approved supplier list and QA related issues 18. Perform other tasks and activities as directed by Director, RA/QA APAC

18. Perform other tasks and activities as directed by Director, RA/QA APAC

or

Call us on 9819212098

**Salary**: ₹700,000.00 - ₹1,100,000.00 per year

Ability to commute/relocate:

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

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

**Speak with the employer**
+91 9819212098

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