Matrix Medical Devices, on behalf of one of its Clients, is recruiting for a full-time Regulatory and Quality Manager in Cleveland, OH. Client is a rapidly growing small business, with multiple new product development programs.
Role Description
This is a full-time on-site role for a Regulatory and Quality Manager (Client) in Cleveland, OH. The Regulatory and Quality Manager will be responsible for overseeing regulatory compliance, managing quality systems, and ensuring adherence to industry standards. This role involves developing and implementing regulatory strategies, conducting product registrations and submissions, and collaborating with cross-functional teams to ensure compliance with regulations and standards.
Qualifications
Experience in medical device regulatory affairs and quality management (OTC preferred)
Knowledge of FDA regulations, ISO standards, and other relevant regulations
Strong organizational and project management skills
Excellent communication and interpersonal skills
Attention to detail and strong analytical skills
Ability to work independently and as part of a team
Bachelor's degree in a related field, such as biomedical engineering or life sciences
Certification in regulatory affairs or quality management is a plus
Experience with medical devices in multiple jurisdictions is beneficial
Interested candidates
Please send CV and contact information via LinkedIn.