Compliance Project Manager - Ballaigues, Switzerland
Dentsply Sirona
- Ballaigues, Vaud
- CDI
- Temps-plein
- Lead/Coordinate or support transversal projects of significant amplitude related to QA/RA.
- Support remediation of legacy and private label products technical dossiers to MDR Regulation
- 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.)
- Support Endodontic product change orders and new product development from a Product Compliance perspective, from feasibility up to commercialization and throughout the product lifecycle
- Review design documentation (V&V, user needs, design inputs/outputs, claims, risk management)
- 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 on TF, TD & DHF
- Ensure conformity of all product labelling associated to the product (IFU, Brochure, Web, etc.)
- Provide expert guidance to R&D for the applicable standards and regulation (e.g., IEC 62366, ISO 14457, REACH, ISO 13485, 2017/745 EU, FDA guidelines)
- Interact with Regulatory Specialists to identify product classification and regulatory pathways for certifications (FDA, CE, INMETRO, etc.)
- Support worldwide product registration during peak activities for Regulatory Specialists
- Pilot risk activities according to applicable requirements (i.e., ISO 14971)
- Support the impact assessment of regulatory and standards changes, CAPAs & NCs on the TD, TF & DHF
- Support sites, group, corporate & regulatory bodies' audits & inspections regarding TD, TF and DHF
- M.S. in biomedical engineering, mechanical engineering or similar
- 3-5 years' experience within international multi-disciplinary R&D or QA/RA 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 62366, 14457, 10993 are an advantage.
- Experience in supporting preparation of EU Technical File compilation for notified bodies
- 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 knowledge of office Suite including OneNote