Jason Jegge

• Manage all aspects of CA/QA/RA requirements from start-up to global commercialization.
• Creation, gap assessments, corrections or auditing of clinical, quality assurance, quality control and regulatory controls for compliance.
• Creation, gap assessments, corrections or auditing of Design Dossiers/Technical files for compliance and submissions.
• Lead Auditor (global) and Technical File Reviewer for registered Notified Bodies.
• Provide services for several small medical device start-ups in pre-funding stages and medium sized funded organizations including:
• Lead writer in the creation, update or audit of regulatory submissions (Design Dossier, Technical File, Clinical Evaluation Reports, Traditional, Abbreviated and DeNovo 510(k));
• Clinical trial work (animal, First In Man);
• Design and/or perform verifications and validations for all technologies listed including aging (accelerated and real time), Biocompatibility, facility including CDA and DI Water systems, product performance, packaging (including serialization controls and techniques, contamination and sterilization controls (Aseptic/ Dry Heat/ ETO/Gamma/Steam) and transit testing;
• Identify technology, human factors, and usability issues essential to risk management.
• Provide systems for compliance to all guidance and regulatory requirements listed above.
• Create, implement and execute regulatory plans and quality systems including all aspects of Complaint, CAPA, NCR, Document Control, Design Control, MDR, PMS and Vigilance.
• Create, implement and/or upgrade established quality systems for regulatory compliance and clinical needs.
• Management Representative during internal and external audits.
• Conducting assessments of clinical trials, client studies, IDE, procedures, and programs to determine compliance and content. Lead Auditor (global) and Technical File Reviewer for registered Notified Bodies.

Principal Quality representative for Clinical Affairs in site monitoring, First in Man-Phase III, reporting, data analysis and SOP creation for clinical arm.

• Established and implemented quality systems for several clinical trials, 510(k) submissions, ISO registration and global commercialization.
• Managed or supported submission of 4 Technical Files achieving all CE Mark approvals.
• Responsible for FDA Device Establishment Registration, Device Listings and documentation maintenance.
• Directed Document and Quality Control departments working closely with Manufacturing and R&D. Responsible for all aspects of CAPA, NCR, Document Control, Design Control, MDR and Vigilance systems.
• Management representative for all external, US FDA, CA FDB and Notified Body assessments.
• Managed process, packaging and sterilization validations.
• Performed all internal and supplier assessments (with focus on complete turn-key post-sterile product).
• Quality representative during implementation of electronic documentation system.

• Provided guidance and submission activities for all regulatory submissions including animal studies, First in Man-Launch, IDE, PMA, 510(k) and Technical Dossiers.
• Responsible for all aspects of quality systems management including budgeting, compliance, strategic planning and presentations of status updates to the Executive Staff/BOD. Started as employee #20 with no company sales building to over 150 employees, IPO and annual revenue over $20 million.
• Managed quality staff and performed activities within Inspection, Special Projects, and Clean Room operations. Responsible for all aspects of CAPA, NCR, Document Control, Design Control, MDR and Vigilance systems.
• Implemented and maintained quality systems to ensure regulatory compliance for global product launches, strategies and continuing sales.