- Solid Quality/Regulatory and Compliance, Engineering foundation and strong business acumen to drive QMS, Labeling, Engineering, Global Submissions, NPI, transform ops, and challenge status quo. Expert in cross - functional business relationships globally with extensive experience in global regulated industry.
AREAS OF EXPERTISE
- EU MDR 2017/745, IVDR 2017/746
- Regulatory/Compliance Turnarounds
- Market Performance/New Product Introduction
- Operational Transformation
- Process Optimization
- Microsoft (Word, Excel, Power Point, Project, Outlook, Visio, Access
- InfoPath, One Note, Publisher, SharePoint and Explorer), Lotus Notes, Oracle, Peach Tree, etc.
- SAP, Master Control, Documentum, JD Edwards, TrackWise, AS400 BPCS
Sr. Quality/Global RA Reviewer
- Acted as a SME in Q/RA for review/update of medical device product technical documentation, processes, compliance reports, etc.
- Reviewed/updated global strategy/procedures focused on current/pending guidance, regulations, agency/industry initiatives, e.g. EU MDR 2017/745, IVDR 2017/746, ISO 13485:2016, FDA 21 CFR 820/803, ARGMD, MDSAP, etc. to ensure compliance with regulatory strategy is aligned with company objectives.
- As a Sr. Technical Writer reviewed/updated Labeling, IFU, Supplier Mgmt./General QMS, Vigilance, Post Market Surveillance and UDI requirements, etc.
- Wrote/reviewed technical files as applicable.
Sr. Global RA Advisor
- Oversaw/managed regulatory activities.
- Drove project timelines to coordinate compilation, review, and submission process for Medical Devices and IVD products for OB GYN purposes and clinical studies, subsequent amendments, including labeling, all interactions and communications with global regulatory agencies from product inception to approval, including regulatory support during Pre-Approval Inspections.
- Attended/participated at related meetings and compiled/reviewed global submissions.
- Drove project timelines to coordinate compilation, review, and submission process for Post-Approval submissions, including labelling, all interactions and communications with the regulatory agencies worldwide, including final review/approval of these submissions.
- Participated in product launch preparation.
- Provided strategic regulatory input for product issue resolution, coordinate, prioritize, and provide day-to-day regulatory support throughout product life cycle.
- Provided strategic position/landscape for new products as well as identify and reduce internal/external barriers to accelerate the approval process.
- Advised project teams and Global RA department members of potential areas of concern and new governmental and regulatory developments.
- Final reviewed global regulatory submissions and provide technical input for Quality Overall Summaries, R&D reports, supporting technical documentation, and present regulatory strategy.
- Final reviewed other department submissions. Provided decision-making on complex issues.
- Provided guidance and direction to R&D, Ops, Mfg., Clinical, QA, Marketing and Product Mgmt. groups throughout the development and submission process to ensure all submission related documents (Technical Files, DHF, DMR, DHR, P&PC, Labelling Specs, Packaging Specs and Clinical Evaluation Reports) are assembled and reviewed on an ongoing basis, with problems identified and addressed concurrently.
- Communicated/followed up with global regulators, Notified Bodies, Marketing Authorization Holders (MAH), Designated MAH (DMAH), In-Country Reps, and Sponsors based on global market requirements.
- Interacted/communicated with Project Mgmt. on submission and project timelines.
- Served as regulatory rep to Remediation Project teams to achieve compliance.
- Reviewed internal/external change requests as well as associated documentation and provide effective regulatory strategy to support change which is compliant with global standards/regs.
- Used/remained current with internal/external electronic submission initiatives.
- Prepared/reviewed new products Regulatory Strategy.
- Revised departmental SOP, maintained new/legacy products international submissions
- Developed/submitted Letter to File, Regulatory Assessments, Change Notifications, among other required regulatory information.
- Prioritized workflow to maximize efficiency.
- Participated/represented department at project meetings.
- Ensured approved products and databases are monitored on a regular basis for updated patent and exclusivity information that may affect potential or pending submission approvals.
- Interfaced with internal/external legal counsel/Business Development on patent infringement issues, paragraph IV certifications, and notices to patent holders.
- Conducted regulatory review of innovator products, associated patent and exclusivity status, including pediatric extensions for new product submissions.
- Conducted regulatory due diligence for internal and/or external R&D projects.
Sr. Supplier Quality Engineering Consultant
- Reviewed design drawings/processes with suppliers to assure inspect ability/compliance to global regulations and standards.
- Worked with suppliers to improve product and process compliance through onsite workshops, development of pFMEA/Control Plans, and assist with correlations studies and inspection plans.
- Reviewed/engaged with supplier process improvements, process validations, supplier initiated change notifications, and FAI expectations to assure internal and external processes are adequate to meet specification.
- Worked with suppliers to assist, in writing and executing protocols and conducting validations per internal requirements.
- Managed supplier qualifications including use and development of questionnaires, audit plans, conducting supplier audits, and engaging with suppliers toward closure of audit findings.
- Gathered/reviewed supplier Maintenance Repair or Operating (MRO) material list to assure product risk is mitigated.
- Compiled/reported on supplier performance metrics/statistics.
- Evaluated/determined reduced or increased inspection plans based on supplier performance and controls.
- Initiated/assisted suppliers with CAPA and assured actions were adequately closed.
- Trained/assisted supplier quality personnel in inspection techniques and the use of new equipment.
- Assisted in the design/development of methods/tooling for the test/inspection of articles.
- Worked with supplier to ensure that suppliers operate per established requirements.
- Assisted in writing/developing of quality mgmt. system processes, work instructions, and forms with suppliers and internal purchasing control requirements.
- Managed complaint, NCR, and CAPA investigations related to product quality/compliance to international standards and regulations from suppliers.