2 jobs found in Selzach, Solothurn

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    • solothurn, solothurn
    • contract
    Do you want to work in a big medical devices company? Do you have experience in Project Management for Medical Devices? You should then read the following lines! Our client, based in the Solothurn area, is looking for a Project Manager - Regulatory Affairs for a one year contract. Job Description:Support MDR compliance execution work by acting as project manager who has oversight on ongoing MDR compliance work for Trauma/CMF/BIO and drives completion of MDR deliverables. This activity includes but is not limited to:- Coordinate and drive resolving of NB questions to submitted Technical Documentation- Provide regular status updates on MDR compliance progress for Trauma/CMF/BIO to MDR PMO and governance team.- Facilitate resolving of roadblocks and timeline constraints- Support execution of project plan for MDR compliance in Trauma/CMF/BIO business for 2021/ 2022.- Lead regular status update meetings with corresponding teams who are working on individual MDR files and/ or specific topics- Lead and track cross-functional activities as assigned, such as MDR Indication definition and Technical Documentation submissions to Notified Body- Provide project management support for activities needed in preparation for MDR compliance as instructed and assigned. What we need from the candidate:• At least 2 years Project Management experience within Medical Device industry• Basic understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745).• Excellent person interaction skills and reliable and goal oriented work attitude• Experienced skills in MS Office, especially in MS Project• Strong analytical skills• Fluent in English. German in addition, would be an asset. Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. 
    Do you want to work in a big medical devices company? Do you have experience in Project Management for Medical Devices? You should then read the following lines! Our client, based in the Solothurn area, is looking for a Project Manager - Regulatory Affairs for a one year contract. Job Description:Support MDR compliance execution work by acting as project manager who has oversight on ongoing MDR compliance work for Trauma/CMF/BIO and drives completion of MDR deliverables. This activity includes but is not limited to:- Coordinate and drive resolving of NB questions to submitted Technical Documentation- Provide regular status updates on MDR compliance progress for Trauma/CMF/BIO to MDR PMO and governance team.- Facilitate resolving of roadblocks and timeline constraints- Support execution of project plan for MDR compliance in Trauma/CMF/BIO business for 2021/ 2022.- Lead regular status update meetings with corresponding teams who are working on individual MDR files and/ or specific topics- Lead and track cross-functional activities as assigned, such as MDR Indication definition and Technical Documentation submissions to Notified Body- Provide project management support for activities needed in preparation for MDR compliance as instructed and assigned. What we need from the candidate:• At least 2 years Project Management experience within Medical Device industry• Basic understanding of MDR requirements regarding required content of Technical Documentation (focus on ANNEX II of Regulation (EU) 2017/745).• Excellent person interaction skills and reliable and goal oriented work attitude• Experienced skills in MS Office, especially in MS Project• Strong analytical skills• Fluent in English. German in addition, would be an asset. Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered. 
    • zug, zug
    • temporary
    Do you have a first experience with complaint handling ? Do you want to participate in the development of a new complaint handling strategy in a multinational environment ? You should then read the following lines!One of our clients, a renowned life science company based in the Zug area, is looking for a new member for their Technical Production Complaint team. They offer a mission of 9 months at first, with the possibility of extension. Tasks:Assess current post market activities to understand scope of how feedback is received, captured, trended and fed back into various teams and assess gaps against various Medical Device and combination product requirements utilizing current gap analysis and by interviewing customer interfacing teamsCollaborate with quality and regulatory to align on the approach to take going forward, regarding feedback gatheringWork with customer interfacing teams to establish processes required and ensure implementation in the QMS for the applicable Medical Device product (Konektom, MSPT, titration device (Peg IM, Avonex)) in line with the expectations of ISO13485 and EU Medical Device RegulationWork with TPC team to ensure correct implementation of feedback loop from Use error and feedback to allow correct classification, trending and input into usability, performance and safety requirements Work with TD/ PPD to ensure correct implementation of updated design control and risk management procedures through translating TPC feedback data to design/ risk management documents for medical devices and combination devices The mentioned tasks sound appealing to you ? Do not waste a second then, and apply now!
    Do you have a first experience with complaint handling ? Do you want to participate in the development of a new complaint handling strategy in a multinational environment ? You should then read the following lines!One of our clients, a renowned life science company based in the Zug area, is looking for a new member for their Technical Production Complaint team. They offer a mission of 9 months at first, with the possibility of extension. Tasks:Assess current post market activities to understand scope of how feedback is received, captured, trended and fed back into various teams and assess gaps against various Medical Device and combination product requirements utilizing current gap analysis and by interviewing customer interfacing teamsCollaborate with quality and regulatory to align on the approach to take going forward, regarding feedback gatheringWork with customer interfacing teams to establish processes required and ensure implementation in the QMS for the applicable Medical Device product (Konektom, MSPT, titration device (Peg IM, Avonex)) in line with the expectations of ISO13485 and EU Medical Device RegulationWork with TPC team to ensure correct implementation of feedback loop from Use error and feedback to allow correct classification, trending and input into usability, performance and safety requirements Work with TD/ PPD to ensure correct implementation of updated design control and risk management procedures through translating TPC feedback data to design/ risk management documents for medical devices and combination devices The mentioned tasks sound appealing to you ? Do not waste a second then, and apply now!

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