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Regulatory Affairs Manager (m/w) – Full-time (40hrs/w)

Graphic Designer (m/w) – studentische Hilfskraft (10-15 hrs/w)


Regulatory Affairs Manager (m/w) – Full-time (40h/w)

We are looking for a Regulatory Affairs Manager to join our team at Humotion GmbH located in Münster (DE). In this position you will be responsible for leading and managing regulatory related processes for Humotion GmbH. The focus will be on leading the regulatory process from design and development until final market release for our new medical product SmartVia Assessments. We at Humotion see regulations and norms not as an annoying hindrance but as input to streamline processes and assure high working standards.

If you are looking for a challenge and are interested to introduce, shape and improve norm compliant processes – keep reading!

Key Responsibilities

  • Key manager for all regulatory questions with a focus on MDD, MDR, RoHS, GDPR
  • Manage, design and improve regulatory processes needed to achieve compliance
  • Monitoring of QM processes
  • Manage consultancy contacts which support regulatory processes
  • Manage technical file for medical devices to ensure quality and compliance
  • Ensure operations adhere to the company’s policies and procedures
  • Contribute to investigations and handling of Non-Conformities (NCIR’s), Complaints (CER’s), Corrective and Preventive Actions (CAPA’s)

Knowledge and technical skills required

  • Degree in medical technology, technical science, law, or economics (BSc / MSc or equivalent). Preferably with specialization in regulatory affairs.
  • 1-2 years of relevant experience in a similar position
  • Experience with MDD 2007/43 EG and relevant norms, e.g. 14971, 60601 and 13485
  • Understanding and living risk management
  • Technical affinity (software and hardware) and willingness to communicate with developers on a technical level
  • Excellent skills in German and English, both written and spoken
  • Willingness to take responsibility
  • Enjoy team work and communication
  • Excellent office skills and document management
  • Highly recommended: affinity with data protection and experience in design and development of medical devices

Who we are

Becoming a leading provider of mobile monitoring systems has been our goal at Humotion for almost a decade. Founded in Münster in 2008, we specialize in capturing, analyzing and processing human motion data using close-to-body sensors and develop corresponding high-tech products and services for the sports and medical market. To do so, we uniquely combine current key technologies from diverse research areas, such as iWear, biofeedback, microprocessor and sensor technology.

What we offer

We offer you a challenging position – full-time– in an interdisciplinary and ambitious team with creative freedom for your own ideas. We meet at eye level, live flat hierarchies and practice short decision-making. Flexible working hours and a healthy work-life balance are a matter of course for us. You can expect a collegial approach in a productive working environment with a start-up character and garden, in the heart of Münster, not far from the promenade and the cathedral. You live in another city and do not want to move? No problem! We are used to work with remote teams.

Interested? Send us your application with credentials, earliest availability and salary expectations via hr@humotion.net.

For any questions concerning the position, you can contact us via hr@humotion.net.

05-11-2018

 


Graphic Designer (m/w) – studentische Hilfskraft (10-15 hrs/w)

We are looking for a Graphic Designer to join our team at Humotion GmbH located in Münster (DE). Your focus will be on creating graphic content in both print and electronic media for product information, marketing materials, the company website, and social media accounts. We are looking for someone who can easily convert ideas into concrete visual designs and who can handle a fast-paced working environment.

Key Responsibilities

  • Create visual aspects of marketing materials, website and other media, including infographics
  • Consult with marketing and engineering teams to create cohesive designs
  • Put together disparate elements of a design created by another professional, such as icons, photographs and other components
  • Build on and expand the current Humotion CI

Knowledge and technical skills required

  • Student in Design, Marketing or related discipline
  • Experience with Illustrator, Photoshop and InDesign, specifically with mockups, web design and print
  • Desirable: Experience working with WordPress templates
  • Desirable: Photography skills
  • Adaptive design eye and skill
  • Good language skills in both English and German
  • Excellent communication skills and willingness to take initiative

Who we are

Becoming a leading provider of mobile monitoring systems has been our goal at Humotion for almost a decade. Founded in Münster in 2008, we specialize in capturing, analyzing and processing human motion data using close-to-body sensors and develop corresponding high-tech products and services for the sports and medical market. To do so, we uniquely combine current key technologies from diverse research areas, such as iWear, biofeedback, microprocessor and sensor technology.

What we offer

We offer you a challenging position in an interdisciplinary and ambitious team with creative freedom for your own ideas. We meet at eye level, live flat hierarchies and practice short decision-making. Flexible working hours and a healthy work-life balance are a matter of course for us. You can expect a collegial approach in a productive working environment with a start-up character and garden, in the heart of Münster, not far from the promenade and the cathedral.

Interested? Send us your application with portfolio and earliest availability via hr@humotion.net.
For any questions concerning the position, you can contact us via hr@humotion.net.

08-11-2018