Quality And Risk Manager

ABOUT CLUE

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.

Founded by Ida Tin, Clue is a VC-­backed startup based in Berlin helping over 10 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

The Position

We are looking for someone with experience in both Quality (or related role) and Risk Management, ideally with a background in medical device products. An interest or experience in usability/human factors engineering would be a plus. This role will be highly cross-functional, taking part in activities across the life-cycle of the product and interfacing with several teams, e.g. quality and regulatory affairs, product design, software development, quality assurance, data science, medical board, and customer support. 

Deliverables:

  • Being an internal representative for product-related processes (Product Design and Software Development)
  • Responsible for our Risk Management process and all related documentation in line with ISO 14971
  • Coordinating risk management activities (identification, analysis, evaluation and control) across teams and across product lifecycle, such as by organising and hosting interactive cross-disciplinary sessions 
  • Working closely with the Product and Engineering teams during new feature development, in particular with regards to the Change Control process and Design and Development documentation requirements according to ISO 13485 and IEC 62304
  • Working closely with the UX researcher in some of the Usability Engineering tasks (ISO 62366)
  • Working closely between the Engineering team and other teams involved in Post-Market Surveillance and Vigilance, and using their outputs to maintain up-to-date Risk and Clinical documentation 
  • Managing product non-conformities, supporting their technical investigation and and determining corrective and preventive actions (CAPAs) where appropriate
  • Contributing to the preparation of regulatory submissions, by ensuring that product documentation needs are met (working closely with Project manager)
  • Delivering and taking part in internal audits as well as handling external audits
  • Providing training and support to teams as required
  • Ready to support other Quality and Regulatory activities within the team as required 

Qualifications:

  • Minimum two years experience in Quality / Risk Management in a regulated product industry, ideally medical device, or even Software as Medical Device (SaMD)
  • Experience with ISO compliance, document control practices and audits under a quality management system, ideally ISO13485 (or ISO9001) and ISO14971 (or  other risk standards)
  • Excellent written and spoken English
  • Experience or interest in software risk or cybersecurity 
  • Experience or interest in usability / human factors engineering 

Characteristics:

  • You want to make an impact by delivering safe and helpful products to people
  • You thrive in an interdisciplinary and culturally diverse environment.
  • You enjoy bringing stakeholders together and mediating/facilitating collaborative exercises.
  • You’re a great communicator, confident and empathetic.
  • You have great attention to detail and organisational skills.

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, a free on-site therapist and low-cost massages in the office
  • Learn and grow with a personal education 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.

Clue is committed to providing an environment of mutual respect, where equal employment opportunities are available to all applicants and team members. Our users are global and multicultural—and we want our team to reflect this. If you need assistance or accommodation due to a disability, please contact us.