Regulatory compliance manager will be responsible for the establishment of Quality Management System as per ISO 9001:2015, ISO 13485: 2016 and MDR 2017/745 in the stainless steel instruments manufacturing company. After the establishment of Quality Management System, this person will be responsible for implementation, trainings, Internal Audits and other related activities.
1. A diploma, certificate or other evidence of formal qualification, awarded on completion of a university in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
2. Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
· Strong science background;
· Excellent research and writing skills;
· Professional demeanor;
· Ability to interact with clients auditors and government employees;
· High level of organization.This is an office position and reports to the Director of Marketing. Compensation is negotiable based on experience.