Deputy Manager, Regulatory Affairs

Job Description

Job Description Summary

To assist in the analysis and improvement of existing regulatory processes through regulatory activity immersion.

• Support regulatory efforts required to comply with new and existing regulations (e.g., FDA Medical Device Regulations and Guidelines, MDSAP) and other requirements including changes to FDA guidelines and applicable international standards
• Leading efforts for UDI including US, EU, and International requirements
• Support efforts for Technical File creation and remediation, collaborating with cross-functional teams for required content
• Support regulatory impact assessments for change controls and other RA/QA items
• Collect, store, and maintain regulatory documentation and assists in managing the data structure of the regulatory network (PIM, DMS, etc.)
• Proven ability to interpret medical device Quality System Regulations
• Assists in preparing, auditing, editing, and publishing registration documentation, as needed
• Support business export control (BEC) listing of product for release globally per RA requirements
• Support the review and approval of product labeling, promotional, and advertising materials as needed
• Performs other duties and assignments as required

Job Description

P3-14314

Required Skills

Optional Skills

Primary Work Location

IND Gurgaon - Signature Towers B

Additional Locations

Work Shift