Medical Device Risk Management

Work Experience

Regulations Now! Teaneck, NJ, USA

Global Regulatory and Product Registration Consultant.

February 2018 – Present

Working with clients to assess their regulatory and quality systems and leading them in the transition of meeting domestic and international regulations, specifically MDD/MDR, MDSAP,

ISO 13485:2016, ISO 9001:2015, Technical Documentation and submissions both international and domestic and Risk Management. Consultancy offered includes global registration, Presentations, Training, Gap Analyses, Gap MDR/IVDR, MDSAP Audits, system and process set-up and follow up on Notified Body compliance issues. Also, as a Lead Auditor, have been performing MDSAP audits on clients on behalf of a Notified Body (Intertek Business Assurance)

NERAC, Inc., Tolland CT, USA

Senior Director, Global Regulatory Affairs and Quality Assurance / Senior Clinical Analyst

August 2017 – February 2018

Led Nerac’s Medical Device Practice Group in offering a comprehensive suite of regulatory,

quality, and compliance solutions including: clinical evaluation reports, Technical Files, MDR,

MDSAP gap assessments and transition to MDSAP/ISO 13485:2016, ISO 9001:2015, post-

market surveillance, internal audit and supplier audit program and support, risk management,

training, and more. In-depth expertise of current relevant national and international

regulations and standards affecting medical device, invaluable to clients navigating in

ever-evolving markets. Vast working knowledge of FDA, Quality System Regulations, ISO

9001/ISO 13485, CE marking requirements and current, Medical Device Directive, FMEA and

risk analysis, validation/verification, design input, output, and reviews, Subcontractor auditing

and certification and Statistical techniques.

Intertek Business Assurance (Notified Body), Lowell MA USA

Medical Device Lead Auditor and Trainer.

June 2015 - Aug. 2017

Audited client sites to latest standard requirements and regulation (MDSAP, MDD, CMDCAS, ISO 13485:2003, ISO 9001:2008); Non-Active devices, Software, Risk Management, Engineering, Follow up on Corrective and Preventive Actions, Technical File Review. Conducted training for clients on internal auditing program and practices and on the new ISO 9001:2015. Job involved heavy traveling both domestic and international. Trained in Technical File review.

Qualified for (among other codes)

MD 0103 - Non-active othopaedic and rehabilitation devices

MD 0104 - Non-active medical devices with measuring function

MD 0106 - Non-active instruments

MD 0202 - Non-active orthopaedic implants

MD 0203 - Non-active functional implants

MD 0303 - Other medical devices for wound care

MD 1109 - Active devices for patient positioning and transport

MD 1111 - Software

MD 1301 - Monitoring devices of non-vital physiological parameters

MD 1302 - Monitoring devices of vital physiological parameters

TUV Rheinland of North America (Notified Body), Monsey NY

Lead Auditor Medical Device,

May 2011-June 2015

Worked with 25 clients annually with regards to regulatory and Quality Management

Systems, compliance to international standards and regulations (to include European, Canada).

Job involved heavy traveling both domestic and international. Auditing to regulations and

Standards, complaints, corrective and preventive action systems and follow-ups on critical

Processes and programs, Certifications and Technical Files review.

Consultant, Monsey, NY

March 2011–May 2011

-Implemented programs to comply with domestic and international regulations and standards.

-Generated policies and procedures to support programs and continual improvement.

-Perform employee training.

-Conducted audits to assess compliance, initiated investigation and root cause, corrective and preventive action programs and followed up on resolutions and closure.

-Program schemes included ISO, ICH, OSHA, CLIA, HIPPA, GxP, MDD.

Stryker Orthopaedics Corporation, Mahwah, NJ

RA Consultant

Nov. 2009 – February 2011

-Facilitated projects and activities with various Stryker’s divisions (Germany, Ireland, France, Switzerland and India)

-Submitted special 510(k) to FDA, addressed deficiencies.

-Generated 510(k) Letters to File to address deviations.

-Reviewed Custom Implant and Instrument DHFs to ensure compliance with global regulatory requirements. Approved and released products for shipments on Oracle.

-Determined label marking and updated Technical Files. Assigned GMDN codes.

-Reviewed and approved ECNs and assessed impact of changes on labeling and CE marking.

HydroCision Incorporated, Billerica MA

QA/RA Manager,

March 2006 - March 2009

Developer and manufacturer of medical devices with indication for use in the spine area, based on fluidjet technology.

-Established and managed risk management process based on ISO 14971:2007 and recall process

-Submitted application of Class III license to Health Canada.

-Submitted applications for certificates from FDA for foreign governments.

-Established Technical Files to meet EU requirements.

-Managed Device Master Record files, and Device History Records.

-Managed Change Management and Document Control system.

-Worked closely with and audited subcontractors on various quality issues.

-Member of the design team. Reviewed and approved risk analyses / FMEAs.

-Managed Training and calibration programs.

-Conducted internal audits to assess compliance, improve quality system and Prepare facility for external audits.

-Maintained all production batch records, MDRs and Device Listing.

Waters Corporation, Worldwide Corporate Headquarters, Milford, MA

Quality Systems Lead Auditor / Continual Improvement Project Mgr.

2002-2006

Waters Medical Device Manufacturer (Class I and II) develops, manufactures and markets UPLC (Ultra Performance Liquid Chromatography) and HPLC (High Performance Liquid Chromatography) instruments and related software and accessories into the European market.

-Key player in the implementation of ISO 13485 program. Executed the yearly internal audit program.

-Integrated facilities and a new business unit into the Quality Management System.

-Developed and delivered training to new auditors from two sites.

-Integrated 21 CFR Part 820 and ISO 9001:2000 requirements into the internal audit system.

-Managed the CAPA program. Generated, monitored and ensured effective implementation of improved processes.

-Developed course materials and trained employees on the Quality Management System ISO, 21 CFR Part 820 and audit preparation.

-Reviewed all revisions and updates of corporate level procedures for compliance.

-Established 24 Month Review process to ensure processes stay current.

-Audited software tools to assess compliance with software validation and 21 CFR Part 11 requirements (Telelogic, SDMS).

-Advised departments on implementing and incorporating software tools to comply with software validation and 21 CFR Part 11 requirements (Management Document Viewer, Training Manager and Calibration Manager).

Administrator and user of QSet software tool (OTS) for scheduling yearly audits and the CAPA system.

-Played a key role during ISO Registrar audits. Main contributor to the success of 3-year recertification audit and surveillance audits.

-Presented quality metrics, results of audits, CAPAs and status of various

programs at management reviews.

-Review and approved IFUs against 510K and Design Dossiers.

-Provided training on Regulatory Affairs processes.

SQA Services, Inc., Los Angeles, CA

Sr. Quality Auditor / Independent Consultant

March 2009 – September 2009

-Tying together twenty years of experience in quality working as an independent third-party

Auditor and consultant for this fast-paced high-profile group. Responsible for project-based

Auditing and corrective action follow-up, working with CROs on clinical site data management, clinical project management, clinical monitoring, and cGMP-compliant suppliers on a host of

issues related to quality and regulatory compliance.

-Audited a CROs to ICH for GCP on behalf Pharmaceutical companies.

-Implemented OSHA and CLIA programs at a chemistry lab.

Pro-Pharmaceuticals, Inc., Newton, MA

GMP Consultant (On assignment)

2002-2009

Worked on a contract basis for an R&D group developing technologies that reduce the toxicity and improves the efficacy of currently used drug therapies. Audited CRO clinical information reporting, Case Request Forms, clinical data management and patient related data. Assessed sponsors and clinical service providers per ICH for GCP, audited Master Drug Files, IND, as well as Active Pharmaceutical Ingredient (API) subcontract manufacturing facilities (Bulk and Aseptic Fill). Generated checklists based on ICH Guidelines and CFR 21 Part 211. Generated SOPs, and reviewed CMC packaging for compliance.

GlycoGenesys, Inc., a Biotech start-up company, Boston MA

Quality Manager

1999-2001

Company developed an anti-cancer drug to help patients with colorectal, pancreatic and prostate cancer.

-Generated SOPs to comply with ISO 9001, FDA/cGMP.

-Worked with subcontractors, Labs and consultants and scientists.

-Generated yearly audit schedule of various companies to GMP, GLP and GCP.

-Audited contract manufacturers and Laboratories.

-Coordinated material review meetings to ensure timely disposition on nonconforming material and samples.

-Reviewed and approved batch records and test reports.

Adhesive Packaging Specialties, Inc. Contract Manufacturing, Peabody MA

Quality Development and Safety Officer

1996-1998

Supplier of B-Staged adhesive films, Pre-forms and other styles of single and multi-component resin materials.

-ISO Management Representative implemented and managed quality systems.

-Trained employees on ISO, quality concepts and process.

-Managed staff of five employees and QC Laboratory.

-Implemented and managed the internal audit program. Audited company processes and suppliers.

-Managed the purchasing function. Established supplier assessment program.

-Implemented and managed the Corrective and Preventive Action program.

Interacted with suppliers and customers.

-Reduced customer complaints by 60%.

-Acted as a Plant Manager in his absence. Managed production lines to meet daily requirements

-Sales representative for selected customers.

Independent Consultant (ISO program implementation) 1993-1996

Implemented quality management systems at companies in various industries.

Led several corporations through ISO 9001 registration audits without major non-conformances

(Bijur Lubricating Corporation, ADE Corporation, Adhesive Packaging Specialties, Inc.).

Established Internal Audit, CAPA and Management Review programs. Trained employees on regulations and standards.

Additional prior roles included:

Quality Control Manager – Cable Harness and Board Assembly House

Program Manager (New Product Introduction), Project Leader – Hi-Technology field

Manufacturing Support Engineer - Hi-Technology field

Training and Certifications:

1) EU MDR training and certification by Intertek 2021

2) Lead Auditor Certification, May 2011, Oriel STAT A MATRIX, Cert # 113992,

3) Assessor of Quality System, May 1992, Kennedy & Donkin Quality Engineering, Manchester, UK

4) Health Canada MDR/CMDCAS Canadian Medical Device Conformity Assessment System, 2012, Accademia Qualitas, Cert # M-2286

5) Various other training to include FDA/GMP regulations, GxP Auditing, ISO, SAP.

6) Qualified for the MDSAP scheme – 3/2017

7) Others:

ISO/IEC 27000-Series-Security Standards, MDD, CE Marking, IVD, ISO 9001:2015, EN ISO 13485:2012, EN ISO 14971:2012, ISO 13485:2003 (under CMDCAS), GMP/GLP/GCP, 21 CFR 820, 21 CFR part 210 and 211, ICH, OSHA, CLIA, HIPAA, 510(k), JPAL, ISO 22716, ISO 14001, Q7 and Q9.

Education

M.A. in Business - Framingham State College, Framingham, MA USA (1989)

B.S. in Industrial Engineering - Northeastern University, Boston, MA USA (1979)

PROFESSIONAL AFFILIATIONS

Regulatory Affairs Professional Society

END of CV

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