Job Details

This is a 100% remote role

Minimum of 2 years in regulatory, preferably 3-4 yeas of experience

Top skills:

• Understanding and actual submission experience
• Regulatory experience
• Strong communication skills
• Engineering Change orders and labeling

Updates from Manager

• EU submission experience required
• Experience working with engineering change orders
• No school experience or academic experience will work for this role
• Need to have actual submission experience
• Bachelor’s degree or master’s degree needed or any science degree
• This role is 100% remote
• Hosting meeting and be a leadership voice would be nice to have
• Class 3 medical device experience is a plus
• Pharma industry experience will not work
• Someone who is well organized
• Providing documents that they need
• US, EU, international submission is a requirement
• Project is working on EUMDR changing regulations
• Looking for 2 regulatory contractors to join this project
• Some EUMDR experience is nice to have
• Individual will be conducting worldwide changes to product
• Tracking submissions
• Good with excel and projects and documenting
• EUMDR understanding
• Any direct submission experience is also nice to have
• Candidates will be remote
• If the candidate is in MN local that would be great but open for remote candidates as well
• Hands on regulatory submission experience
• Good communication skills
• 50% international and 30% EUMDR 10% in US side as well, 10% on engineering side
• Doing submission in Asia pacific, Canada, Asia, south Asia, Latin America