Supports post market domestic regulatory activities regarding complaint analysis, MDR submissions, post market risk assessments (HHA), supports maintenance of the product Technical File in support of CE Marking, and risk management file updates.
Responsibilities May Include:
• Applies knowledge of device regulatory requirements (FDA and/or other International Regulatory Agencies) to support the Post Market Surveillance MDR/ADE reporting process and evaluates complaints for MDR reporting utilizing product knowledge and Decision Trees.
•Processes basic submissions of MDR/ADE; develops and reviews complex MDR/ADE submissions with assistance from QA Management.
• Lead post market risk assessment process and escalate critical issues for field action determination. Facilitate and manage the recall process when necessary.
• Provide support to R&D in the ongoing maintenance of product Technical Files that support CE mark.
• Understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820, 803, 806; ISO 13485).
• Strong knowledge of post market regulatory compliance requirements
• Reasoning ability, support and prioritize projects.
• Expert at maintaining and assisting others to develop and maintain Good Documentation Practices
Education and Experience
• Bachelor's Degree required
• 4+ years' experience in medical device
• Travel up to 10%