Product Compliance Manager (f/m/d)

... a young, up-and-coming healthcare company situated in the heart of Hamburg. Based on our steep growth course and successes (e.g. FOCUS Wachstumschampion 2020), we have set ourselves the ambitious goal of becoming THE digital health tech partner for health and prevention, trusted by people all over the world. To this end, we offer easy-to-use diagnostics in the form of home lab test kits, perfectly matched recommendations and products, and individual consultations. True to our vision: We want you and your loved ones to stay healthy. That’s why we empower people to take their health into their own hands!

This is where YOU come into the picture. Our team in Hamburg needs you to join us immediately as a

Product Compliance Manager (f/m/d)

About the Role:

Product Compliance Manager will work in the product management team, managing the international requirements for cerascreen products. Working together with our Quality and Regulatory Affairs Department and our Country Managers, you will be responsible for building market entry requirements into the cerascreen quality and regulatory system and product management system. Whilst planning for and ensuring that cerascreen continues to meet requirements, renewing registration, updating country operations as cerascreen products are developed, changed and adapted.

• Develop international regulatory compliance concepts and processes for our products
• Work closely with country managers, product management and quality and regularly affairs to achieve regulatory compliance of all our products
• Assist the relevant teams in preparing medical device technical documentation (in German and Englisch) required for current and new international markets identified
• Contribute to an international product change management system ensuring that country registrations remain up to date and valid
• Coordinate post-market surveillance & vigilance on internationalised products

• You have a university degree in business administration or natural sciences
• You are fluent in both English and German, minimum CEFR level B2 proficiency in both German and English.
• You bring a strong project management skills and experience with you
• You are able to work as part of a team and independently
• You have excellent internal and external stakeholder management skills
• You understand regulations (such as MDR/IVDR) and technical documentation, in both English and German.
• You have experience in engineering, science, policy, quality and regulatory, technical documentation, product compliance, product design or similar fields highly desirable
• You have good computer skills, including Google Sheets and/or Excel.
• Strong administration and data management skills round up your profile

• An exciting, guaranteed diversified job in the best city location
• Varied and diverse range of tasks
• A unique opportunity to drive digitisation in the health sector
• A high degree of independent work and personal responsibility
• A young team with flat hierarchies, direct communication and start-up feeling
• Free use of our health tests, among others also the tests around the topic Corona
• Attractive discounts on supplements, rich fruit and vegetable basket and regular team events
• Subsidy for the HVV ProfiCard
• High-quality equipment for flexible, mobile and digital work

We are proud to be an equal opportunity employer and therefore offer equal opportunities to all employees and applicants, regardless of gender, age, disability, nationality, religion or sexual orientation.

Do you feel addressed? Then we look forward to receiving your application! Your personal contact person is Sina Bieler.

We are looking forward to getting to know you personally!