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Medical Compliance Manager

ArdenVent

Your Impact As Medical Compliance Manager you will have the opportunity to improve the quality of our product, lead our medical device development to success and accelerate our time to market. As a new charitable organization, we have many motivated volunteers and valuable technological sponsorships but lack the experience and workflows of an established medical device company. If you have experience in this industry you will be able to save many lives in developing countries, far beyond the pandemic, with minimal effort.

Your Responsibilities

Work with engineers to review requirements and organize design items Research and plan steps to successful FDA/MDR submissions of our medical device files Lead weekly meetings, assign tasks to volunteers, provide guidance, etc. Ensure compliance of volunteers with our QMS Requirements

Knowledge of Quality Management Systems (ideally ISO 13485) 5+ years of full-time work experience in the Medical Device Industry Solid experience in Design Control Significant involvement in all aspects of an FDA/MDR submission Experience leading a small team (3-5 people)