Our client, a leader within the Healthcare industry is seeking to recruit an Associate - EMEA Post Market Surveillance on a full-time basis. In this role your responsibilities will include:
Duties and Responsibilities:
Gather complaint information from local organizations and complainants.
Prepare and submit medical device vigilance reports and Periodic Summary reports.
Notify Third Party Suppliers.
Work with plant quality organizations and suppliers to coordinate complaint investigations.
Identify and escalate safety issues to management.
Ensure consistency of EMEA complaint records.
Maintain compliance to regulations and procedures.
Prepare customer response letter/ MOH response.
Able to work in an environment that is highly regulated by procedure and quality system.
Able to work as part of a team
Organized and meticulous
Certification or a strong understanding of Quality Engineering principles and practices.
Previous experience would be an asset
Strong understanding of international medical device regulations.