Product Compliance Manager (mfd)
Job Summary
Bruker is enabling scientists and engineers to make breakthrough post-genomic discoveries and develop new applications that improve the quality of human life. Brukers high performance scientific instruments and high value analytical and diagnostic solutions enable scientists to explore life and materials at molecular cellular and microscopic close cooperation with our customers Bruker is enabling innovation improved productivity and customer success in post-genomic life science molecular and cell biology research in applied and biopharma applications in microscopy and nanoanalysis as well as in industrial and cleantech research and next-gen semiconductor metrology in support of AI. Bruker offers differentiated high-value life science and diagnostics systems and solutions in preclinical imaging clinical phenomics research proteomics and multiomics spatial and single-cell biology functional structural and condensate biology as well as in clinical microbiology and molecular diagnostics.
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We are seeking a Product Compliance Manager (m/f/d) to join the Bruker AXS Division functionally anchored within Global IMS (Quality Management) at our Karlsruhe or Berlin this role you will be responsible for ensuring product compliance across the entire product lifecycle with a focus on functional safety product cybersecurity and regulatory requirements (e.g. CE conformity CRA). You will act as a central interface between management development and external stakeholders driving compliance processes and supporting risk assessments audits and certifications. This position plays a key role in establishing and continuously improving product compliance structures across the international Bruker AXS Division.
- Ensure compliance with all relevant legal and normative requirements for Bruker AXS Division products throughout the entire product lifecycle (e.g. EU Regulation 2023/1230 Cyber Resilience Act IEC/EN 61508 EN ISO 13849).
- Implement maintain and continuously improve a Product Cybersecurity Management System including vulnerability management SBOM monitoring and reporting of relevant security incidents to authorities.
- Implement maintain and further develop the existing Functional Safety Management System in accordance with IEC/EN 61508.
- Coordinate and communicate proactively with management regulatory authorities certification bodies and internal as well as external stakeholders on all product compliance matters.
- Advise and support internal departments in risk assessments technical changes and product compliance topics.
- Plan conduct and follow up on internal and external audits related to product compliance.
- Support the preparation and maintenance of conformity assessments and CE declarations.
- Organize and deliver training sessions on product compliance and related topics.
- Ensure proper documentation monitoring and continuous improvement of product compliance processes.
- Completed university degree (e.g. Electrical Engineering Computer Science Physics Automation Engineering or a comparable field).
- Professional experience in Product Compliance Functional Safety and/or Product Cybersecurity.
- Knowledge of relevant functional safety cybersecurity and product compliance standards and regulations (e.g. IEC 61508 ISO 13849 IEC 62443 CE marking Cyber Resilience Act).
- Structured and analytical working style with strong problem-solving skills.
- Excellent communication skills and the ability to collaborate effectively in cross-functional international teams.
- Professional proficiency in German and English.
Required Experience:
Manager
About Company
Our Luxendo light-sheet solutions have SPIM technology to gently image living organisms or to quickly obtain 3D images of cleared-tissue samples in the life sciences.