Senior Quality and Risk Manager

Clue helps everyone who menstruates to understand their bodies—and to be empowered by that knowledge. Our vision is to enable women and people with cycles to live in tune with their biology, not in spite of it.

Clue is a VC backed startup based in Berlin helping over 13 million people each month get insights into their reproductive health via our Android and iOS Apps. We collaborate with world-leading universities and institutes to advance female health research with our dataset, and deliver essential education about health, periods, and sex via our website, helloclue.com.

At Clue we embrace a culture that values everyones’ uniqueness and lets them flourish as an individual. We are constantly working on creating an environment which provides equal opportunities, regardless of your ethnicity, age, gender, sexual orientation, disability, race, religion, and any other diverse backgrounds. As a part of our team, your unique set of talents will always be appreciated and we’re committed to provide them with a nurturing and safe environment.

As a team, we stand by the values Care, Love for Science, Users, and Effort.

 

Role:

We are looking for an experienced Quality and Risk Management professional to guide our regulated product development efforts, holding the quality and regulatory perspective and supporting continuous improvement.

Reporting to the Head of Quality and Regulatory Affairs, being an expert enabler and inspiring team-player as part of the Q & R team, as well as an influential figure in our collaborations with other teams by:

  • Leading the compliance and effectiveness of our product development-related processes (including Design and Development, Maintenance, Change Management, Risk Management, Usability Engineering, Traceability, Problem resolution)
  • Advising the technical subject matter experts, advocating for quality, supervising process performance, and enhancing the quality and design of our documentation, processes and systems; as well as IT & Infrastructure initiatives on regulatory impact
  • Assessing Design Changes and identifying impact and implications for our medical device documentation and downstream process activities (e.g. risk management)
  • Maintaining compliance of our Medical Device File / Device Master Record / Technical File according to our applicable market requirements
  • Leading the Risk Management process activities across the lifecycle of new and existing products, facilitating workshops with relevant stakeholders
  • Assessing severity associated with software bugs and incidents as they arise (post-market or prior to release), including where appropriate managing CAPAs to address the root cause.
  • Contributing to wider projects with a growth mindset and a collaborative/inclusive team spirit

 

About you:

  • 6+ years experience in Quality and Risk Management with software medical device products (or at least medical device containing software)
  • Deep knowledge of key medical device standards and regulations (ISO 13485, ISO 14971, IEC 62304, IEC 62366, 21 CFR 820, EU MDR 2017/745)
  • Experience with medical device regulatory audits (FDA, Notified Body)
  • Excellent written and spoken English and communication skills

Nice to have:

  • Life Science Degree with research and outreach experience
  • Up-to-date formal training certifications in any of the above mentioned standards
  • Experience in Usability / Human Factors Engineering 
  • Experience in IT Security

 

Benefits:

We believe personal growth is essential for professional growth which is why we offer all the standard benefits, plus some that are uniquely Clue.

  • Care for your body and mind with free weekly yoga, and a free on-site therapist
  • Learn and grow with a professional and personal development budget 
  • Work your way in our child-friendly and dog-friendly office. We’ll help with relocation if you’re not already in Berlin.
  • Five weeks of paid vacation each year, a competitive salary, participation in our all-employee option pool, and the option to join the company pension plan.
  • Flex Fridays: One day per week where Cluebies can put their health & wellbeing first, stay energized and maintain a sustainable high level of productivity.

During the Covid-19 pandemic, we are working remotely from home in Berlin.