Sr Executive - Regulatory Affairs

Job Description

Responsibilities: Plan and manage development of high-quality regulatory documents including CTA, & Post Market Surveillance (PMS) reports and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements Ensure all filings (including DMFs) are maintained as per the regulatory requirements and consistent with the product development and life cycle Participation in regulatory meetings with Health Authorities Recommends changes for labelling, manufacturing, marketing, and clinical protocol for regulatory compliance. Knowledge: Working knowledge of 510(k), MDR 2017/745 and working knowledge of 21 CFR 820 -Quality System.