Combination Product & Medical Device Technical Expert
CSL Behring
Bern, Kanton Bern, CH
vor 6 Tg.

CSL Behring the global biotherapies provider driven by its promise to save lives and to improve the quality of life for people with rare and serious medical conditions.

For our location in Bern, we are looking for a Combination Product & Medical Device Technical Expert Our Medical Device and Primary Packaging Development organisation is focused on the design, development and commercialisation of a diverse portfolio of device technology solutions to enable delivery of CSL’s innovative therapies that improve patients' quality of life, solve unmet medical needs and save lives.

The successful candidate will lead and apply their expertise to the technical development of primary packaging, medical devices and combination product, from early development through to commercial launch and postmarket support.

Primary technologies include vials, prefilled syringes, vial transfer systems, auto-injectors, on-body wearable injectors.

  • The person will apply their knowledge of the regulatory landscape to ensure standard compliant documentation, working to Quality Management Systems such as ISO 13485, and 21CFR820 Design Control, risk management to ISO14971, and EU MDD / MDR requirements, compilation and maintenance of Design History Files, verification trial / commercial manufacture support;
  • the person will also participate in risk management and design review activities. Main Responsibilities and Accountabilities : Working directly with and managing of 3rd parties (CMOs, Design Consultancies) contracted to design, manufacture and / or deliver medical devices or medical device components.

    Author, review, approve usability and functionality study protocols and reports, and analyze study data. Author technical specifications, design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and DHF creation / maintenance DHF), conformity assessments and risk management documentation.

    Ensure designs, methods, and processes comply with guidelines and standards issued by regulatory and standards organizations (e.

    g., FDA, IEC 62366-1 and 60601, ISO 14971). Authoring, compilation and maintenance of Design History File content, Conformity Assessments, and Design Verification Plans.

    Support marketing, QA and production regarding technical clarifications concerning medical devices and primary packaging components.

    Qualifications & Experience : MSc or PhD in natural sciences (pharmacy, biology, medicine) or technical engineering (mechanical, chemical, biomedical, engineering).

    Thorough understanding of Medical Devices and Combination Products with at least 5 years of proven track record in the creation and maintenance of technical files and Design History Files by the aid of different software solutions or even by hand.

    Risk Management experience in drug delivery devices (e.g. vial transfer systems, auto-injectors, prefilled syringes, wearable injectors).

    Ability to adhere to standards, preferably with knowledge of MDR (EU) 2017 / 745 and FDA guidelines of compiling DHF for medical devices / combination products.

    Strong communication skills for collaborating with cross-functional teams. Ability to work both independently and with a team in a collaborative setting.

    Proficiency in English & German. We are looking forward to receiving your online application. Applications must include a motivation letter and CV, as well as letters of references and copies of relevant transcripts and / or diplomas in the original language.

    Please include all these in one document together with the CV. CSL Behring is committed to provide equal employment opportunity for all.

    Worker Type : Employee Worker Sub Type : Regular

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