Our client, a leader within the Healthcare Industry is seeking to recruit an Associate (EMEA Post Market Surveillance) to join their team on a full-time basis.
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 with 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;
Paragon Europe is an innovative, international EU affairs, advisory, recruitment & compliance company with head offices in Malta and Brussels. From its inception, Paragon Europe has striven to realise excellence by competing with cutting edge peers in the ultra-competitive market of EU funding. Paragon Europe works with both private and public organisations, NGOs, universities, educational institutes and agencies offering various services related to European funded programmes such as Horizon 2020, Erasmus+, Youth Workers, COSME, PON/POR and more to supply the best workforce possible.
- Certification or a strong understanding of Quality Engineering principles and practices;
- Previous experience would be an asset;
- Strong understanding of international medical device regulations.