As Technical Documentation Project Leader, you'll be the main coordinator for all update and maintenance activities for Endodontics product technical documentation according to the applicable regulations and standards to Medical Devices. Together with R&D, Clinical Affairs, QA, RA, Ops, you'll drive relevant projects forward. You will also ensure compliance and consistency of overall QA/RA strategy during major design and process changes or system development involving several products.
This position is to be based either in Ballaigues, Switzerland or Munich, Germany.
- Coordinate update and maintenance activities for legacy technical documentation
- Ensure implementation of all required actions to update technical files for full compliance to the European 2017/745 Medical Device Regulation (List of Applicable Standards, BSA, CED, GSPR, DDS, Testing TP&TR, Claims, CE Labeling, RMR, V&V, TDI etc...)
- Provide support to Clinical Affairs and R&D in the creation of biocompatibility and usability studies
- Lead MDR labeling changes
- Coordinate update and maintenance of the legacy Design History Files and 93/42/EEC MDD Technical files respective to the intended Markets
- Coordinate necessary updates of 93/42/EEC MDD legacy product risk management to semi-quantitative
- Manage sub-projects, in relation with R&D, QA department, aiming to improve the technical file management process (change control, risk management process, device master records, design history files)
- Support R&D and Ops during major product or process change controls to maintain compliance of modified technical files.
- Ensure overall QA/RA strategy consistency in case of major new system development involving several products. Support sites, group, corporate and regulatory bodies' audits & inspections, more specifically respective to Product Technical Documentation, Technical Files, Design History Files.
- Support the Regulatory Affairs Specialists for Worldwide product registrations and registration file maintenance.
- Propose evolutionary changes and means to insure optimal conduct of his/her tasks and responsibilities.
- Ensure application of new requirements on TF/TD/DHF and elaborate associated remediation plans.
- Support complaints department to provide technical answer to Health Authorities
Requirements and Qualifications
- Bachelor's or master's degree or equivalent in one of the following areas: Biomedical, Sciences, Engineering or similar
- Minimum of 5 years' experience in a Quality Systems / Regulatory Compliance environment
- 3-5 years' experience in the medical device industry preferably in dentistry and/or endodontics
- Excellent understanding of the European Medical Device Regulation (93/42/EEC MDD & 2017/745 MDR)
- Strong knowledge of medical device and main international regulations as well as quality management standards (e.g. ISO 13485, US FDA 21 CFR part 820, Canadian Medical Device regulation, Japanese QMS Ordinance MHLW M.O. 169, Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), MDSAP)
- Solid experience in Risk Management (ISO 14971)
- Excellent communication skills in English (C1 min.) and either
- French (B2/C1) and German is a plus, or
- German (B2/C1) and French is a plus
- Solid knowledge with Office suite