Susann
Hoch
susann.hoch@arcondis.com Human Resources Germany
About Arcondis
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries, with their particularly demanding requirements on quality and regulatory aspects. We have been managing challenges and solving problems for our clients in the areas of compliance, business processes,
information technology, and digital transformation since 2001. We create value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
Open Position
Mission
Tasks and responsibilities
Identification, independent analysis and assessment of compliance-related topics in the MedTech industry
Working with cross-functional team members to ensure customer success and deliver value
Implement new, enhance and improve existing IT tools, and ensure software CSV compliance
Development and implementation of compliance solutions (e.g. Software as a medical device)
Establish a close collaboration with the software development, product management and customer-oriented units to strengthen produced documentation materials
Meeting with engineers, programmers, and project managers to learn about specific products or processes
Advising, supporting, managing regulatory, technical and quality management consulting projects for clients in the medical devices and SW toolchain
Studies
Your profile
Bachelor/Master degree in a Scientific, Technical or IT related discipline
Relevant work experience at minimum of 3 years in Process/Product Engineering and/or Process/Product Development in MedTech industry with a focus on product life cycle management, quality assurance, regulatory affairs, or IT
Previous experience in medical technology and product development is a plus.
Project management experience with focus on quality assurance & compliance with further interfaces to IT-related topics (e.g., toolchain, security, cloud SaaS, data management, data integrity, data privacy) and change management activities on product lifecycle.
Communicative, structured, used to taking initiative, and have an eye for details.
Comfortable communicating with authority across the organization, be willing to share your knowledge, and build strong relationships internally and externally.
Guide our customers to best possible results by thinking out-of-the-box and establish lean workflows to address client challenges & bottlenecks
Familiarity with Quality related processes (e.g. CAPA, Complaints, Non-Conformance, Product Surveillance, Change Management)
Ability to independently gather information from subject matter experts to develop, organize and write design documents, technical drawings, product specifications, user acceptance testing, procedure manuals, technical specifications, and process documentation
Competence to work as part of a team or individually on a project, to independently evaluate situations and propose potential solutions, to manage multiple tasks and prioritize assignments to meet deadlines.
Theoretical and applied knowledge of standards, norms and regulations (e.g. FDA QSR, MDR, ISO 13485, ISO 14971, IEC 62304, ISO 27001, 21 CFR Part 11, 21 CFR 820 and equivalent regulatory bodies, GAMP, cGMP and CSV)
Theoretical and applied knowledge about MDR, IVDR and additional international regulations
Very good understanding of complex technical systems
Excellent analytical, systematic working and problem-solving skills with the ability to untangle complex issues
Good IT skills in Microsoft Office and G-Suite, as well as knowledge of Project Management tools like Jira, Confluence
Business Fluent in English and German
I want to apply for the following position.
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