Quality and Regulatory Affairs Manager

A company is looking for a Manager of Quality and Regulatory Affairs.

Key Responsibilities

Provide administrative support including scheduling meetings, preparing reports, and maintaining audit and CAPA schedules

Prepare for internal and external quality audits by organizing documentation and ensuring compliance with relevant standards

Assist in implementing and monitoring quality processes and systems to meet organizational standards and objectives

Required Qualifications

5 - 10 years of experience with ISO 9001 : 2015 and ISO 27001 : 2022 standards

Certification with ASQ or Exemplar Global is a plus

Self-starter with the ability to work independently and engage with others proactively

Proficiency in MS Office Suite, SharePoint, Salesforce, LITMOS LIMS, and Zendesk

Experience in data collection and analysis related to quality management