Experience

StethoMe®

• Poland
• Wellness and Fitness Services
• 1 - 100 Employee

• VP Regulatory

  • Mar 2021 - Present

  - Leading the Compliance Department and being responsible for regulatory and quality matters; - Supervision over the QMS: o maintaining compliance with the ISO13485:2016 standard, o oversight over the Non-Conformities and CAPA process; o introducing quality system changes to the organization including changes in approach and management of the internal changes, o verifying complaints and its impact on the product, o close cooperation with Production and R&D Departments to provide Quality support and to keep Company and product compliance with required standards, o preparation of QMS procedures and work instructions; - Oversight over the registration process in EU markets: o maintaining regulatory compliance and securing CE marking, o cooperation with Notified Body, o preparing Company for and supporting Notified Body audits, o preparing Post-Market Surveillance documentation and keeping it up to date; - Liaison with Competent Authorities in EU in terms for f product notification as well as responding to any raised questions; - Supervision over the product technical documentation; - Being responsible for establishing the entry path to the US market (via510k) - cooperation with external consultants, determining the implementation timeframe and expected costs; - Leading and supporting product changes from the quality and regulatory perspective (establishing the change significance in terms of MDD 93/42/EEC and MDR 2017/745 requirements); - Conducting internal audits; - Setting the budget for Compliance Department; - Supporting management in the investment round; - Responding to day to day regulatory and quality issues. Show less