Sr. Regulatory Affairs Specialist

The Sr. Regulatory Affairs Specialist  will prepare global regulatory documents and submissions, according to Abiomed standards, for a novel ECMO therapy with recent 510k approval. This key team member will play a crucial role in ensuring that novel therapy is available to patients in need, and they will play a significant role in the growth of this product. If you are detail-oriented Regulatory Affairs professional who is passionate about making a difference in patients' lives every day, we are interested in hearing from you. 

Principal Responsibilities:

• Regulatory lead/representative on project core teams (new product development, manufacturing, obsolescence, new suppliers, etc.) providing regulatory input on all matters
• Performs regulatory impact assessments for manufacturing and product changes for notification to regulatory agencies.
• Prepares regulatory plans and prepares needed regulatory submissions and associated documents for FDA, Health Canada, Notified Bodies, PMDA and ROW countries and secures approvals
• Conducts training programs to educate employees on regulatory processes and requirements
• Communicates with regulatory agencies regarding clarification of or follow-up of submissions under review
• Reviews technical reports for incorporation into regulatory submissions
• Maintains company registration and device listings for global regulatory agencies
• Regulatory liaison/representative in internal or external audits
• Maintains current knowledge base of existing and emerging regulations, standards and guidance documents
• Identifies relevant guidance documents, international regulations and standards and provides interpretive assistance for new filings
• Prepares and maintains technical files as necessary to obtain and sustain product approvals
• Compiles and maintains regulatory documentation databases and tracking systems