Employment Type : Full-Time
Job Opening for Medical Device EU MDR Regulatory Affairs Consultant (2 Roles) - Remote Principle Duties and Responsibilities: Must have EU MDR experience, including knowledge of RA requirements and experience preparing MDR submission for EU Class II and/or III devices. Day to day: Nice to haves:
We are currently working on below mentioned i., e. Job Opening for Medical Device EU MDR Regulatory Affairs Consultant (2 Roles) - Remote. Please let me know if you are interested in applying for the same.
Medical Device EU MDR Regulatory Affairs Consultant - 6 months, Entirely Remote
Environment: Our client is a large medical device company. They are manufacturing a number of class 2 and 3 medical devices. They are in need of a Regulatory Affairs consultant to come in and help with EU MDR.
The consultant will be from the medical device industry, and will have strong experience as an RA specialist. The client needs someone on a senior level to help get their tech files updated to meet the new EU MDR standard. The consultant must have extensive experience working with design dossiers, technical files, and risk management. The consultant will also be working internal SMEs so good communication skills is also a must.
Actively participate in EU MDR core team by attending meetings, collaborating with cross-functional stakeholders, and communicating RA requirements/guidance for submission
Review change orders associated with the MDR project deliverables
Prepare and submit EU MDR submission for applicable device per project schedule
The submissions will be for neuro devices and include electrosurgery forceps, long term and short term antimicrobial catheters, patties/strips, and perforators/drills
Combination device experience preferred for the antimicrobial catheter submissions.
Medical Device Regulatory Affairs EU MDR Consultant – 9 months, Entirely Remote
This consultant will be responsible for updating technical files to meet the new EU MDR requirements. The person chosen for this role will need to have an in depth knowledge of both EU MDD and EU MDR. They will be responsible for reviewing a technical file, identifying where the gaps are in regard to moving it from EU MDD to EU MDR. From there they will be assigning those gaps to cross functional teams, communicating what changes need to be made and tracking the gaps until closure. Once the gap assessment is complete this consultant will be conducting the hands on upgrades required to update the documents.
-identify tech file gaps
-redline technical documentation
-communicate what changes need to be made to cross functional teams
-Assign the gaps to appropriate team and track gaps to closure
-at least 3 years of experience
-Experience under the Medical device directive
- Orthopedics Spine Experience