Compliance Project Manager

Requistion ID: [[id]] 

As member of the Product Compliance Management group, you’ll ensure Quality & Regulatory compliance of dental medical devices all along their lifecycles. You’ll help maintain all technical documentation for Endodontics products across 5 different sites in CH, D, FR, IT & USA. Interacting internationally, 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 or improve processes to guarantee product development compliance for Endodontics medical devices in different global markets.

Product Compliance Engineer 

Main Responsibilities

• 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

Requirements and Qualifications

• 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