Regulatory Affairs Manager

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Description

As Regulatory Affairs Manager you will be the interface between the development and regulation of software-as-a-medical-device (SaMD) products. You will be responsible for implementing a regulatory system in a lean and agile start-up environment that simultaneously ensures regulatory compliance whilst allowing for the fast development of new innovative products. As part of this position you will shape the regulatory approval of our products according to MDR, FDA and other regulatory frameworks as well as be responsible for both external and internal audits.

 

Qualifications (need-to-haves)

  • University degree in a relevant subject with a focus on analytical thinking and precise, reliable working methods.
  • Professional experience in regulatory affairs or in quality management systems relating to medical devices, specifically ISO 13485 or ISO 9001.
  • Strong communication skills in dealing with health and regulatory authorities.
  • Enjoy working with legal texts and researching international guidelines and laws.
  • Familiarity with basic software design and development procedures.
  • Project management experience.
  • Fluency in English.

Nice-to-haves

  • Experience in setting up and further developing QM systems, and/or successful support of an audit.
  • Experience working with standards, e.g. IEC 62304, and regulations relating to SaMDs and enjoyment in applying and deepening this knowledge.
  • A high interest in software development or ideally even first experiences in programming.
  • Experience working with Quality Assurance for SaMD or consumer software.
  • Familiarity with the planning and conducting of clinical trials.
  • Fluency in German.

Job Description

  • Development and improvement of our Quality Management Systems and regulatory documentation for our SaMDs.
  • Track and implement new regulatory requirements and update QMS processes accordingly.
  • Develop design and development processes that comply with the regulations for technical documentation whilst simultaneously allowing for agile software development.
  • Determine regulatory requirements and classification for current and new SaMDs that Alex Therapeutics develops.
  • Perform internal audits and work with external auditors to ensure regulatory compliance.

Working at Alex

  • Doing good – we're all about creating positive impact.
  • Work on a growing product portfolio supporting healthy habits and improving mental health.
  • Learn and develop in a fast-paced startup environment.
  • Play an important part in shaping the future of Alex.
  • Opportunity to join an energetic team of psychologists, designers and engineers.
  • Centrally located office in Stockholm, Sweden with the opportunity to work remotely.

 

Or, know someone who would be a perfect fit? Let them know!

Alex Therapeutics

Norrsken House
113 56 Stockholm Directions

Work on a growing product portfolio

In 2018 we launched our first product, a CBT-based smoking cessation treatment. We currently have several products in the pipeline covering other habits and mental health issues.

Get in touch and we'll tell you more!

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email
@alextherapeutics.com
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