||Responsible for the development of post market clinical research strategies of orthopedic devices to support global regulatory and post market PMCF requirements.
Work closely with cross functional teams Clinical, Medical, Regulatory, R&D, Marketing to develop post market clinical evidence generation strategies that consider evidence needs for EU Medical Device Regulations EU MDR. Facilitate clinical evidence reviews with cross functional team to align on clinical evidence strategies, document, track decisions and risks, and write PMCF Plans.
50/50 shared healthcare cost for the position.
Paid holidays, paid sick days, paid vacation.
A Bachelors degree in Biological Science or related discipline, with a minimum of 4 years experience in the medical device industry or healthcare field is required.
Advanced technical writing skills is required, with demonstrated experience in writing PMCF plans, reports strongly preferred.