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

Date Posted: 5/4/2021

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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?