Our medical device client is looking for a Regulatory Consultant for a 1+ year contract. The Regulatory Consultant will assist in the preparation and EU MDR submission for neuro devices and include electrosurgery forceps, long term and short term antimicrobial catheters, patties/strips, and perforators/drills. They will be responsible for reviewing change orders associated with the MDR project deliverables. They must have EU MDR experience, including knowledge of RA requirements and experience preparing MDR submission for EU Class II and/or III devices. This person will actively participate with the EU MDR core team by attending meetings, collaborating with cross-functional stakeholders, and communicating RA requirements/guidance for submission. Combo-product experience is a plus.
- Education: Bachelor’s Degree required
- Minimum 5 years of experience in the medical device industry is preferred
Remote: Regulatory Consultant (231394)