Regulatory Affairs Manager and Specialist in West Lafayette, IN at Vaco

Date Posted: 5/4/2021

Job Snapshot

  • Employee Type:
    Full-Time
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    5/4/2021
  • Job ID:
    REGUL50547

Job Description

Regulatory Affairs Manager, West Lafayette, IN

Are you looking to advance your career with a stable and growing company? Are you skilled in Regulatory Affairs? Can you provide leadership and guidance to a team? Can you prioritize and develop a regulatory strategy? a Here's what I am looking for ….

  • Provide leadership and oversight over work content related to maintaining and obtaining regulatory clearances/approvals, including Investigational Device Exemptions (IDEs), 510ks, Premarket Approvals (PMAs), design dossiers, Clinical Evaluation Reports (CERs), and other submission documents
  • Author original regulatory documents for submissions in support of Class II and Class III medical device clearances/approvals.
  • Combine technical and regulatory expertise to implement regulatory strategies for medical device development
  • Develop efficient regulatory processes to ensure regulatory compliance and maintenance of regulatory approvals.
  • Have 6+ years' experience?