Consulting in Regulatory Affairs, including regulatory strategy, quality auditing, technical writing, and global product submissions for class I, II and III medical devices and IVD's; as well as combination products:
-Develop strategy and execute objectives for Regulatory Affairs and Quality Assurance functions.
-Quality Management System implementation and revision, multiple platforms.
-Participate and conduct internal and external audits and compliance programs. (GLP, GCP, GMP).

Provided leadership for Regulatory Affairs, Quality Assurance and Clinical Compliance. Responsible for regulatory strategy, planning and guidance for the company and its device development program(s). Budget Responsibility for department. Worked closely with Clinical Operations in execution of clinical trial to support PMA for stroke treatment. Regulatory submissions for both design and manufacturing changes. Developed and fostered relationships with FDA and other agencies.

In a pre-VC environment, as head of the RA/QA/CA department, was responsible for preparation and execution of all regulatory plans and strategy, and acted as Management Representative and interface for external agencies.

Evaluated changes to existing products (class II and class III) to determine regulatory impact, planned appropriate regulatory strategies and completed submissions to FDA. Supported IDE and pre-IDE activities for Cardiac Surgery products, including interface with MAB, SAB, and CMO. Represented Regulatory Affairs on CCB, Product Development Teams, and QAC, perform HHE’s and recall activities. Train, mentor, and supervise other associates.

Evaluated new products (class II and class III) as well as changes to existing products to determine regulatory impact, plan and write appropriate regulatory submissions. Wrote submissions (510(k) and PMA, DD, TF) to appropriate regulatory group, and negotiate during product review cycle. Responsible for Safety Complaint Review and MDR determination. Supported international groups with product filings and approvals.

Responsible for regulatory activities of Aesthetic Business Unit for class II products, including all submissions and regulatory documents for BU products including laser and combination products. Was member of Regulatory and Quality 483 Response Team. Member of recall team, coordinating HHE and recall reporting. Research, write, and file submissions to FDA for product marketing clearance or approval, and negotiate with FDA during product review cycle.

Researched, wrote, and filed submissions to FDA for product marketing clearance (class II) or approval (class III), and negotiated with FDA during product review cycle. Represented Regulatory Affairs on Quality System Review Board (CAPAs, Complaints and Recalls), Change Control Board and Product Development Teams. Participated on Internal Audit Team.

Designed databases for document & data tracking relating to FDA compliance and company's Quality System for class II devices. Coordinated internal and external resources and consultants on CMC section for new product. Wrote policy & procedure documents regarding software validation. Set up database for tracking of Adverse Events, and other clinical trial data. Responsible for formatting, editing, and control of QA documents.

Began tenure in Quality Assurance/Regulatory Affairs as Document Control Clerk, advanced to Systems Analyst - reported to Director of Regulatory Affairs. Acted as Coordinator for Regulatory Submissions of class I and class II IVDs. Created database for tracking documents relating to FDA GMP and ISO 9000 compliance, including Quality Manual, DMRs, and DHFs to ensure document files were in compliance. Set up a database for regulatory tracking of Customer Complaints and System Performance Reports.