Peter Woodcraft

Regulatory Affairs and Quality Management for Medical Devices | Emotional Regulation and Quality of Life for Human Beings

Zella-Mehlis, Thuringia, Germany

About

My passion is the realisation of human potential through improved health, learning and development opportunities. A patchwork career, pioneering a 'gig economy' lifestyle before the term had been invented, I bring a unique blend of advanced skills and wide-ranging experience to the modern workplace.

Experience

  • European Shiatsu School (19 yrs 10 mos)
    • Principal
      Sep 2010 - Present · 15 yrs 10 mos

      Design and implementation of professional Shiatsu training courses leading to a Diploma conforming to regulations set by the Shiatsu Society UK and the European Shiatsu Federation.

    • Director
      Sep 2006 - Aug 2012 · 6 yrs

      Design, authoring and delivery of Shiatsu training courses for adult learners including management of associate teachers. Assessment of student learning and performance and mentoring for graduates as they establish their own clinic.

  • English Language Teacher at Freelance, self-emplyed
    Apr 2011 - Present · 15 yrs 3 mos

    Mentoring and guiding speakers of English as a second language to improve their skills, language autonomy and confidence in all areas of language use

  • Senior Quality and Regulatory Affairs Manager at apoplex medical technologies GmbH
    May 2024 - Mar 2026 · 1 yr 11 mos

  • Lindera (Full-time · 2 yrs 5 mos)
    • Senior Regulatory Affairs, Quality and Cybersecurity Manager
      Jul 2023 - May 2024 · 11 mos

      Leading a small dynamic team to acquire and maintain compliance with EU MDR, ISO 13485 and ISO 27001. Building expertise to take the next steps towards FDA and HIPPA compliance for the US market

    • Regulatory Affairs Development Manager
      Jan 2022 - Jul 2023 · 1 yr 7 mos

    • Technical Writer
      Jan 2022 - Sep 2022 · 9 mos

  • MDR Compliance Specialist at TrichoLAB
    Aug 2019 - Dec 2021 · 2 yrs 5 mos

    Project management of compliance to EU Medical Device Regulation for software as a medical device. Key responsibilities: analysis of process and workflow to define management strategy for regulation compliance; simplification of complex regulatory requirements into measurable, repeatable actions; clear communication of the strategy's aims to all staff; management of internal and external dependencies; analysis of QMS deltas to meet ISO13485