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 a Senior Quality and Regulatory Manager you will administer regulatory compliance requirements as we expand our portfolio of medical devices and enter new regulated markets.
Reporting to the Head of Quality and Regulatory Affairs, you will collaborate closely with Q&R, Legal and Product teams and perform tasks within Regulatory Research for new products and markets, Design and Development, Regulatory Strategy Planning, Communications, Submissions, and Notifications, as well as:
- Lead our regulatory affairs-related activities, bringing sector expertise and regulatory evidence to inform feasibility of product roadmap and identifying solutions to enable it
- Carry our regulatory research for new products and/or new markets
- Support Product and Marketing teams by refining the product vision in a way that optimises outcomes and minimises hurdles
- Own our Regulatory Strategy Plans by identifying the regulatory credentials of our products, and keep track of changes in medical device standards and regulations
- Monitor regulatory status of our competitors (new registrants, incident reports, risks) and compare strategies based on research
- Maintain conformity checklists up-to-date, compile documentation for pre-market submission, perform company device registrations and stay on top of regulatory timelines
- 6+ years experience in QA/RA role in medical device industry
- 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 regulatory research, device classification and regulatory strategy planning
- Experience with regulatory submissions (510k, DeNovo, CE), registration with national health authorities
- Experience with FDA and/or Notified Body audits and communications
- Excellent communication skills in English
Nice-to-have:
- Academic degree with research experience
- Up-to-date formal training certifications in any of the above mentioned standards
- Experience with MDSAP or other regulated markets beyond EU/US
- Experience with public reimbursement
- Good level of German
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.
