Peter Pianegonda

Lead Regulatory Expert @ Gradical GmbH/Hamilton AG

Bonaduz, Graubünden, Switzerland

About

- REACH, RoHS, PFAS, TSCA, etc. for material compliance - risk management ISO14971 for medical industry, ISO12100 for machinery industry - GMP, GAMP5, CSV, Biocompatability ISO 10993 for pharma and life science industry - conformity assessment for LVD, EMC, RED, MaschR, ATEX, UKEx, RoHS, MDR, IVDR, CRA, PPWR, ESPR - customer questionnaire regarding all kind of regulatory affairs - integrated management systems: quality, safety, environement, sustainability - product portfolio and phase-out management - strategic procurement - supplier development, supplier quality engineering, QA of outsourced processes - technical due diligence

Experience

  • Lead Regulatory Expert at Gradical GmbH
    Apr 2023 - Present · 3 yrs 4 mos

  • Hamilton (9 yrs 9 mos)
    • Senior Quality Manager QA/RA
      Dec 2020 - Present · 5 yrs 8 mos

      Business Unit Process Analytics

    • Quality Leader Innovation
      Dec 2018 - Nov 2020 · 2 yrs

      Quality assurance of product development and life cycle management for liquid handling platforms and accessoires within BU Robotics. Regulatory Affairs and conformity assessment regarding LVD, EMC, MD, IVD, IVDR, RoHS. supporting customers in compliance topics.

    • Senior Quality Assurance Manager
      Nov 2016 - Nov 2018 · 2 yrs 1 mo

      Quality Management in new product development, life cycle management. Regulatory Affairs and conformity assessment regarding LVD, EMC, MD, IVD, IVDR, RoHS. supporting customers in compliance topics.

  • Geschäftsführender Teilhaber at AHA-Mode & Alles für die Handarbeit
    Aug 1999 - Present · 27 yrs

    Finance, strategic projects, e-commerce, IT

  • QMS / Conformity Assessment at VITATEC Products AG
    Aug 1995 - Present · 31 yrs

    Freelance for conformity assessement, QMS ISO13485, internal audits, for medtech products

  • Dozent at ibW Höhere Fachschule Südostschweiz
    Feb 2012 - Apr 2023 · 11 yrs 3 mos

    Lecturer of post graduate course "Business Process Management"