Product Compliance Manager (BBBH493996) Vaud, Suisse
For its partner specialized in Medical Devices, Kelly Life Sciences is looking for a:
Product Compliance Manager
(Permanent position)
As member of the Product Compliance Management group, you’ll ensure Quality & Regulatory Compliance of activities all along the product lifecycle. You’ll help maintain all technical documentation for ours Instrumentation/Obturation 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 our medical devices in different global markets.
Your responsibilities:
· Provide expert guidance to R&D for the applicable standards and regulation (e.g., ISO 14457, REACH, ISO 13485, FDA guidelines)
· Ensure conformity of all product labelling associated to the product (IFU, Brochure, Web, etc.)
· Support the maintenance/update of 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 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.)
· 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
Your Profile:
· M.S. in biomedical engineering, mechanical engineering or similar
· 1-4 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 international standards requirements according to IEC 62366, 14457, 10993; IEC 60601 & 62304 are an advantage.
· 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 knowledge of office Suite including OneNote
Your contact at Kelly:
Mrs Cristina Alvarino Bouza
Consultant Professional Staffing Life Science
Kelly Life Sciences Geneva