Process Manager Consultant (Medical Project, Freelance)
PAY ATTENTION: only those candidates who meet the listed requirements will receive an answer!
Location
Ukraine
Necessary skills and qualifications
At least 5 years of process management experience in medical projects
Experience in process establishment in accordance with certification standards: ISO 13485, IEC 62304, and ISO 14971
Extensive experience with the regulation requirements for medical software development for the U.S. (FDA) and Europe (MDR) markets
Experience in medical devices software development for Class IIb and above
Understanding of the unique challenges in healthcare process management, including regulations and stakeholder expectations
Experience in preparing medical project documentation for certification
Strong decision-making, problem-solving, organizational, and time management skills
Will be a plus
Having an auditor certification in medical project development (e.g. ISO 13485:2016 Lead Auditor, IEC 62304 Certified Professional, ISO 14971 Risk Management Auditor)
Roksolana Mariia Yatsyshyn
Recruiter