Employment Type : Full-Time
Job Opening for Class II/III Regulatory Affairs Consultant- Remote We are currently working on below mentioned i., e. Job Opening for Class II/III Regulatory Affairs Consultant- Remote. Please let me know if you are interested in applying for the same. Class II/III Regulatory Affairs Consultant-REMOTE, 40 HOURS/WEEK Project: Our client is a large medical device manufacturer of class II/III endo surgery products. They are in need of a Regulatory Affairs consultant to come in and help complete 30-day notices, change orders, 180-day notices and life cycle management to be submitted to the FDA. Our client is looking for a very hands-on consultant who can be urgent with submission work. Principle Duties and Responsibilities: The consultant will be from the medical device industry and will have done experience with class II and III US submissions. The consultant will need to work with internal resources to locate information and needs to understand what information is required in the 30- and 180-day notices to get it approved. Very hands on role so must be comfortable writing dossiers. These activities are around post market PMA post approvals. Experience tech files, and design dossiers is a huge plus but experience with Class III and PMA submissions is a must. The ideal candidate will have endo experience and will have worked on both 510(k)s and PMAs. If you have experience with Health Canada and EU MDR that is a plus. Required: Medical Device
Reg Affairs
PMA writing/submissions
510(K) experiences
International/ Domestic Regulations
Hands on experience
Class II and III experience
30-day Notice
EU MDR