A BDN client is looking for a LCM Regulatory Consultant to come in and help with the company's lifecycle management. The client is looking for someone from a Regulatory perspective, not Quality. The candidate would be working on Regulatory Submissions, design change, label change, and develop a strategy for everything in LCM. This includes annual reports, gap assessments, pre-audit/audits, etc. The client's primary products are Class II and Class III implants. They would prefer someone who has been the primary writer for these submissions, not just worked on them as a part of a team. Experience in Regulatory Submissions, Change Control, Regulatory Strategy, and Medical Devices are needed. Pluses for this position include experience with 510ks, PMA supplements, and EU submissions.