Clients include: Abbott (AIMD), Merit, DePuy (Class II and Class III implantable), Second Sight (Class III active implantable), Alcon (Class II and III ophthalmic), Ethicon, J&J, Cordis, Advanced Sterilization Products, Omrix/Animas, Aventis Behring, Stryker/Synthes (Class II and III orthopedics), Fresenius/Nephros Inc. (Class III nephrology), Evaheart (Class III cardiovascular), Lifeblood (tissue), Armor HealthcareAdept at regulatory strategy, trained on new 13485:2016 and new MDR, write 510k's (Traditional, Special, De Novo), IDE's, PMA's. IND's, Annual Reports, Pre-submissions, 30, 135 and 180 Day Notices/Supplements, Creation/revision of Technical Files and Design Dossiers, Worldwide product registrations (Canadian licensing, Australia, Japanese shonin, China, South Am. including Brazil etc.). Have prepared for and presented at meetings with the FDA including Panel. Have supported several companies who have been issued 483's, warning Letters and are in remediation. Clinical: Study Start-up, FDA / IRB / IEC approvals, Training Investigator / staff (Protocol, IB, ICF), Monitoring (Monitoring Plan / Trip Reports), Auditing, Clinical Reports, SAE Reporting, Data Integrity, Study Drug / Device accountability, Study Close. Have worked with eCRFs and combination products. QA/Compliance: New MDR, Create/Revise Quality Systems, GAP Analyses, Risk based Supplier Qualification Systems, CAPA Systems, perform Internal Audits, Supplier Audit (API, OEM, sterilizers, CRO, labs etc.). Perform mock FDA and Notified Body Audits.Background: Wilkes University, Graduated 1989 Major Biology, Minor Chemistry (pre-Med). Have worked in regulated industry for 24+ years. Regulations: Have audited to and am knowledgeable of: 21 CFR Part 11, 50, 58, 210, 211, and 820. In addition, 13485:2016, CAN/CSA-ISO 13485, and Council Directive 93/42/EEC, Medical Device Directive (MDD) including knowledgeable of new revisions, cGCP/ICH, cGMP, cGLP, MDR.

Supplier quality, 510k, QMS

PMA Supplements and Amendments for manufacturing changes

Direct Reports: 0Responsibilities: 510k's, IDE, PMA writing, Technical Files, Design Dossiers

Direct Reports: 3Reports to: CEOResponsibilities: Received approval on IDE for End Stage Renal Therapy 28 Jan 2007. Updated Quality System from ISO 9001:2000 to ISO 13485:2003. Project Manager for domestic and international clinical studies including audit/evaluation/contract of CRO, initial evaluation of proposed study sites, central laboratory and data management group and activities, provided regulatory input on Test Protocols, Study Protocol, Informed Consent Document, Case Report Forms and Investigator's Brochure to assure they meet regulatory requirements, preparation of FDA (IDE) and IRB/IEC submissions. Audit labs to assure cGLP compliance, perform site monitoring and/or auditing during study, perform cGCP/ICH, cGLP and 13485:2003 training for employees, prepare and submit SAE Reports/ Annual Reports/ Amendments/Supplements, write necessary clinical and regulatory SOPs and Guidelines. Act as Management Representative presenting Management Reviews and preparing Quality Plans and Objectives, Auditee for Regulatory Agencies.

Direct Reports: 12Reported to: CEO Responsibilities: Created a Quality System compliant with QSR/cGCP/ISO 9001 regulations. Oversaw two QC groups. Audited and qualified critical suppliers including hosting facilities (cGCP) and consultants. QA all phases and paperwork produced during the Software Development Life Cycle assuring validation was complete and product met all regulatory requirements (cGCP) prior to product release. Performed Regulatory and Quality Training (internal and external) including but not limited to cGXPs, QSRs, ISO 9001, 21 CFR Part 11, HIPAA, Software Development Life Cycle and Project Management Training. Performed RA/CA Training for the Product Development Group (cGCP/ICH), new RA employees, and clients.

Helped write a BLA, several CBE-30's and Pre Approval Supplements. Worked on remediation and closing FDA 483's

Direct Reports: 4Responsibilities: Implemented regulatory strategy to assure product positioning and timely regulatory approvals of various devices and biologics for spinal support/diseases. Prepared Supplements and Amendments, Annual and Safety Reports, and Phase IV Commitment Packages as necessary. Compiled Design Dossiers and Technical Files. Prepared packages and presented at Panel Meetings. Performed site monitoring and study close-out activities. Compiled Clinical Study Data for Annual Reports and Regulatory Submissions. Audited Clinical Study Sites, Central Laboratories, CRO. Auditee during FDA audits (cGMP of manufacturing site, cGCP of Study Sites and on-site clinical study paperwork). Assured all clinical data queries were resolved prior to submission. Wrote Regulatory and Clinical SOPs.

Regulatory Lead. Worked closely with Engineers to ensure Product was classified correctly, correct standards were being followed, Protocols and Reports were written in a manner that would support device approval. Wrote 510(k)'s, IDE's, PMAs, Supplements, Annual Reports. Responded to FDA Request for Information.

Direct Reports: 1Responsibilities: Created a Quality System compliant with cGMP/cGCP/cGLP regulations. Provided regulatory input on Test Protocols, Study Protocol, Informed Consent Document, Case Report Forms and Investigator's Brochure to assure they meet regulatory requirements. Prepared FDA (IND) and IRB/IEC submissions. Wrote sections and compiled IND Submissions for a device / biologic for treatment of stroke and subarachnoid hemorrhage. Performed site start-up and monitoring (cGCP) activities. Wrote and submitted Amendments/Supplements/SAE Reports. Audited drug manufacturer (cGMPs), testing laboratories (cGLPs), and animal testing facilities. Wrote clinical/quality and regulatory SOPs. Managed Document Control System/CAPA System/Supplier Qualification System.

RA Specialist Direct Reports: 4Responsibilities: Wrote 510K's, Obtained ISO 9001 Certification on Quality System and updated documents to be compliant with QSRs as well as cGMPs. Reviewed and commented on documentation for inclusion in Design Dossiers/Technical Files and FDA submissions. Compiled Design Dossiers/Technical Files and provide registration packets for international product registration (6 continents). Performed internal and supplier audits including Sterilization Facilities and Testing Laboratories. Wrote Regulatory and Quality SOPs. Acted as Management Representative and presented Management Review. Managed the Customer Complaint/Vigilance and CAPA Systems.

Reason for Leaving: Plant ClosureResponsibilities: Created cGMP/ISO 9001 compliant Quality System. Managed the Document Control System, Change Control, Complaint and CAPA Systems for a company that was moving from R&D to Marketed product. Audited manufacturers and suppliers for compliance with applicable regulations.

Worked as a part of a team to obtain ISO 9001 Certification. All aspects of Pharma QA/QC including: receiving drug inspection, receiving component inspection, label release, line clearances, drug retain, batch record review, final product release, clinical product labeling and packaging. QA representative for validation of refrigerators, inspection and labeling machinery, and packaging machinery.

Performed analyses of blended medical grade gasses utilizing GCP and continuous flow equipment. Performed equipment calibration and maintenance. Kept accurate lab notebooks to support test results. Ran calibration linearity studies to assess ranges that required equipment re-calibration prior to executing tests.

Performed over 30 bench analyses, operated GC, HPLC, FTIR and Mass Spec on liquid and solid samples. Test results were being used for court trials in the state of NJ. Proficient in cGLP's including proper asceptic technique, proper sample storage, chain of custody and laboratory notebook maintenance. Wrote test procedures, cleaning procedures, managed MSDS and assured reagents were not expired.