Gene Redig

Experience

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  Medtronic

  Sept 1991 - May 1996

  Corporate Quality Sr. Staff Specialist

  A leader in medical technology - alleviating pain, restoring health, and extending life for people around the world.

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  Mallinckrodt

  May 1996 - Oct 2000

  Quality Manager

  Mallinckrodt, now part of Tyco Healthcare, manufactures and markets medical products.

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  Sartorius Stedim Biotech

  May 2004 - Oct 2007

  Director of Quality

  Integrated Biosystems, now part of Sartorius Stedim Biotech, supplies Controlled Freeze-Thaw technology solutions to the biopharmaceutical manufacturing industry. Sartorius Stedim Biotech is a provider of cutting-edge equipment and services for the development, quality assurance, and production processes of the biopharmaceutical industry.

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  Circle Medical Devices

  Jan 2008 - Jul 2008

  VP, Quality and Regulatory Affairs

  Circle Medical Devices (CMD) is a Medical Device Engineering Services and Contract Manufacturing firm with extensive experience in bringing medical devices to market. CMD offers expertise in digital and analog engineering, software engineering, mechanical engineering, chemistry, industrial design, and contract manufacturing.

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  Intuitive Surgical, Inc.

  Aug 2008 - Jan 2009

  Director, Regulatory Compliance

  Intuitive Surgical, Inc. (Nasdaq: ISRG) is the global technology leader in robotic-assisted minimally invasive surgery (MIS). The Company's da Vinci® Surgical System offers surgeons superior visualization, enhanced dexterity, greater precision and ergonomic comfort for the optimal performance of MIS. The da Vinci System enables surgeons to perform even complex procedures such as open-heart surgery through 1-2 cm incisions.

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  Medtronic

  May 2009 - Jun 2009

  Consultant

  While consulting for Medtronic CoreValve, I developed SOPs, Forms, training, etc. to ensure compliance to FDA/ISO regulations.

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  J-PAC LLC

  Jun 2009 - Oct 2009

  Consultant

  While consulting for J-PAC, LLC, I stepped into the Quality/Regulatory leadership role (on-site) for 4 months to provide stability, stewardship, and mentoring of existing employees until a suitable replacement could be hired.

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  Volcano Corporation

  Oct 2009 - Oct 2010

  Consultant

  While consulting for Volcano Corporation, I helped manage the quality and regulatory aspects for this medical device company to ensure that the operational business was in compliance with cGMP, regulatory requirements, the specific Quality Manual, and conducted according to the relevant SOPs (e.g., Product Development, Risk Management, MDD Essential Requirements, regulatory submissions [510(k), CE, Japan, Latin America, Asia Pacific, etc.]).

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  MyRAQA

  Oct 2010 - Sept 2014

  Sr. Director

  Myraqa was a full-service IVD Regulatory consulting firm. Founded in 1998 as a solo practice, Myraqa grew to include leading experts in RA, QA, Design Control, Process Development, Systems Integration and Project Administration.Myraqa served a wide range of clients, including established players, up and comers, and even stealth startups. Myraqa worked on a full range of IVD applications in the US and EU, including PMAs, pre-IDEs, IDEs, 510(k)s, de novo 510(k)s, and EU technical files.While consulting for Myraqa, I developed entire Quality Systems (i.e., Quality Manual, SOPs, Forms, training, etc.) for 9 clients to ensure compliance to FDA/ISO regulations. I also stepped into the Quality/Regulatory leadership role for a client (on-site) for 4 months to provide stability, stewardship, and mentoring of existing employees until a suitable replacement could be hired. Show less

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  Illumina

  Sept 2014 - Jan 2018

  Quality/Regulatory Management Consultant

  Energetic, versatile, innovative, results and people-oriented professional with proven track record in quality management, regulatory affairs, cross-functional project management, and business operations. Demonstrated ability to drive leading-edge technology-based solutions both from an internal and external point of view. Accomplished in medical device, biotech, and high-tech sectors in US and global markets. Highly regarded for ability to identify and resolve problems and to work effectively with personnel at all levels. Hands on experience with:• Quality Systems• FDA/ISO Regulations• Qualification/Validation• Risk Management• Software Development• Regulatory Affairs• FDA/ISO Auditing• CE/UL Marking• CAPA/CCB Management• Product Development• Compliance Management• Medical Device Single Audit Program (MDSAP)• GCP for Medical Devices• Usability Engineering• New EU IVDR and MDR Show less

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  Self-employed

  Jan 2018 - Jan 2019

  Quality/Regulatory Management Consultant
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  Oriel STAT A MATRIX

  Jan 2019 - Nov 2023

  Director Quality and Regulatory Consulting

  Gene is an energetic, versatile, innovative, results and people-oriented professional with proven track record in quality management, regulatory affairs, cross-functional project management, and business operations. Demonstrated ability to drive leading-edge technology-based solutions both from an internal and external point of view. Accomplished in medical device, biotech, and high-tech sectors in US and global markets. Highly regarded for ability to identify and resolve problems and to work effectively with personnel at all levels. Show less

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  Self-employed

  Dec 2023 - now

  Quality/Regulatory Management Consultant

  Gene brings over 25 years of medical device, biotech, and high-tech sector experience and was responsible for software and quality management systems (QMS) projects at these companies.His experiences span risk management, quality systems, FDA/ISO regulations, EU MDR/IVDR, CAPA, qualification and validation, FDA/ISO auditing, MDSAP, GCP, usability engineering, and software development. With many consulting projects under his belt, Gene’s key strengths include his ability to identify and resolve problems and work effectively with personnel at all levels. Show less