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:
As Post-market surveillance and Vigilance Manager, you will be responsible for operating and improving our existing vigilance and post-market surveillance system, as well as for the assessment and execution of our reporting obligations to regulatory authorities.
You will use your medical background to make clinical safety assessments of our complaints and medical device reports, having the opportunity to participate in clinical evaluations for regulatory submissions and gain experience in the preparations of post-market evaluations and reports within a fast-paced environment.
As part of the regulatory/quality team, you will work closely and report to the Senior Medical Safety Lead, as well as interfacing with several teams including Customer Support, Engineering, Science and Data Science. Main responsibilities include:
- Contribution to the execution of the post-market surveillance plan and the related activities, operation of Vigilance and Reporting processes in line with legal/regulatory requirements in our relevant markets, and suggestion of improvements in such systems
- Lead the regulatory and medical safety qualification of complaints and incidents (e.g. seriousness & causality assessment), individually authoring such assessments and reporting them to the relevant authorities as appropriate
- Provide medical safety interpretation of findings for individual case reports, and in connection to those, execution of regulatory safety documentation & submission including final review of safety relevant adverse event coding (MedDRA)
- Coordinate cross-functional activities required for PMS and Vigilance with other teams
- Author Post-market surveillance reports and PSURs
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Create medical device Clinical Evaluation and Post-market Clinical Follow-up plans and reports, also for future marketing authorisation purposes (e.g. for CE application)
- Take part in communicating with users by doing regulatory reviews on user-facing contents
- Ensure that safety and other medical issues are considered at all stages of the software development life-cycle within the agile framework (e.g. participating in product-releases by being responsible for clinical safety considerations)
- Take part in internal audits as well as contributing to external audits
- Provide training and support to teams and support other Quality and Regulatory activities as required
About you:
- Medical Degree or equivalent with clinical skills
- Minimum 1 year experience in a regulated environment (with pharmaceuticals or medical device companies), handling medical devices or Software as Medical Device (SaMD)
- Experience in working under a quality management system or GxP requirements, handling clinical safety data and post-market reports
- Advanced analytical skills in complex product-related issues
Nice to have:
- Experience in assessing events’ seriousness and causal relationship with the medicinal product
- Experience in medical writing (e.g. authoring company clinical comments, medical reviews), working with MeDRA is a plus!
- Experience in working with EU MEDDEV/ MDR, FDA CFR 820 and Medical Device Reporting, other regulatory requirements
- Basic drug and/or medical device development expertise
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.
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Care for your body and mind with free weekly yoga, and a free on-site therapist
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Learn and grow with a professional and personal development budget
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Work your way in our child-friendly and dog-friendly office. We’ll help with relocation if you’re not already in Berlin.
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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.
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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.
