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Product Compliance Manager (QA/RC) - Ballaigues, Switzerland or Munich, Germany

Dentsply Sirona

 
Ballaigues, Switzerland or Munich, Germany
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Dentsply Sirona
Product Compliance Manager (QA/RC) - Ballaigues, Switzerland or Munich, Germany

As member of the Product Compliance Manager group, you'll ensure Quality & Regulatory Compliance of activities all along the product lifecycle. You'll help maintain all technical documentation for Endodontics products, and you'll provide valuable quality & normative guidance to R&D, Marketing, Labeling, Clinical Affairs and Manufacturing, helping ensure efficient and successful product introduction worldwide. Finally, you'll help implement appropriate processes to guarantee product development compliance for Endodontics medical devices in different global markets.

This position is to be based either in Ballaigues, Switzerland or Munich, Germany.

 Main Responsibilities

  • Support the maintenance/update of Endodontics Technical Dossiers (TD), Technical Files (TF) and Design History Files (DHF) according to applicable international regulations & standards (e.g. EU MDR)
  • Assess impact of (and act upon) manufacturing or design changes or non-conformities on TF, TD & DHF
  • Support implementation of appropriate controls to ensure Endo Product records are maintained/archived/updated to meet applicable record retention and regulatory requirements
  • Support Endodontic product change orders and new product development from a Product Compliance perspective, from feasibility up to commercialization and throughout the product lifecycle
  • Work closely with multifunctional Product Development teams to ensure compliance with design control, safety, functional goals requirements with a patient-related focus in accordance with all applicable requirements (i.e. Corporate, Consumables Group, FDA, MDD, MDR, etc.)
  • Review design documentation (V&V, user needs, design inputs/outputs, claims, risk management)
  • Interact with Regulatory Specialists to identify product classification and regulatory pathways for certifications (FDA, CE, INMETRO, etc.)
  • Provide expert guidance to R&D for the applicable standards and regulation (e.g. IEC 60601, 62304, 62366, ISO 14457, RoHS, WEEE, REACH, ISO 13485, FDA guidelines)
  • Ensure conformity of all product labelling associated to the product (IFU, Brochure, Web, etc.)
  • Manage product and process change control processes
  • Pilot risk activities according to applicable requirements (i.e. ISO 14971)
  • Support sites, group, corporate & regulatory bodies' audits & inspections regarding TD, TF and DHF
  • Support the impact assessment of regulatory and standards changes, CAPAs & NCs on the TD, TF & DHF

 Requirements and Qualifications

  • M.S. in biomedical engineering or similar
  • 3-5 years' experience in within international multi-disciplinary R&D organizations in the area of medical device design control and regulations (21 CFR part 820, 93/42/EC Directive, 2017/745 EU Regulation, SOR 98/282, MHLW M.O. 169), quality management standards (ISO 13485), and risk management (ISO 14971); knowledge of the dental industry is an asset
  • Knowledge of international standards requirements according to IEC 60601, 62304, 62366, 14457
  • Experience in supporting preparation of 510k/PMA submissions, EU Technical File compilation and other ROW product registration
  • Excellent communication and presentation skills in English (C1); French and/or German would be a plus
  • Strong team player with the ability to build productive relationships in a dynamic international environment
  • Autonomous and independent decision-taker
  • Result-orientation combined with conscientiousness in execution
  • Excellent knowldege of office Suite including OneNote

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