AssistMe ist die digitale Plattform für den Gesundheits- und Pflegebereich. AssistMe ermöglicht anwenderfreundliche Lösung für Fach- und Führungskräfte in Pflege und Medizin. Unser Ziel ist die Arbeitsprozesse zu erleichtern und Dokumentationsabläufe zu reduzieren.
At AssistMe, we are developing an IoT platform capable of solving the biggest problems in healthcare. We are driving human-centred innovation in digital health. We are shaping new business models in medicine, elder care and health tech to support both caregivers and those in need of care. Our tech solutions give older people and those in need of care the chance to live more independently. We are improving care through innovation to care for the people who once cared for us.
As our Regulatory Affairs Manager you will take ownership of the regulatory strategy and its implementation at AssistMe. This is a very critical role to the company's future and will help fulfil relevant national and international regulatory requirements. You will work closely with our product owners and marketing and technical leads to make key product and go-to-market decisions.Aufgaben
- Develop and execute AssistMe's global regulatory strategy working closely with senior management team
- Lead our medical device certification process and oversee the continuous compliance for medical software in EU (CE, MDD, MDR) and preferably also US (FDA).
- Keep abreast of legislative developments in the countries or regions in which the company distributes its products or services
- Gather, structure, and formalize relevant information in order to fulfill regulatory requirements
- Create, implement, and document processes together with internal cross-functional teams like Engineering, Product, Quality management, R&D
- Perform periodic internal and external audits on company procedures and processes
- Build relationships and align with external stakeholders such as the notified body as person responsible for regulatory compliance according to MDR Article 15
- Minimum 3 years of relevant work experience in regulatory affairs for medical devices, preferably in hardware, firmware and software services and knowledge of all applicable standards in EU and preferably also USA
- Experience with device certification (IEC60601) and Quality Management Systems compliant with the ISO 13485, preferably also compliant with 21 CFR part 820
- Ability to own regulatory processes working closely with hardware and software development, clinical and business teams
- Work in a reliable, precise, and solution-oriented way
- Excellent communication skills both written and spoken
- A highly hands-on approach and ability to work in dynamic start-up culture
- Fluent language skills in English, German is a plus
Ideally you have:
- A university degree in a relevant area such as law, medicine, pharmacy, engineering or another scientific discipline
- Ability to adapt and thrive in a fast-paced, start-up environment, ability to iterate on existing set-ups and new concepts
- A demonstrated ability to take new cutting-edge products to market
- The ability to deliver results and high tolerance for ambiguity
- The chance to set up the department of regulatory affairs from scratch while implementing your own ideas
- Full-time unlimited contract
- Competitive salary
- Flexible working hours
- Free drinks & fruits
- Hardware of your choice
- Subsidized membership to a Berlin sports club with 450+ locations
- New and well-equipped office directly at S-Bahn Tiergarten in Berlin
Work with the best
- Join an agile, cross-functional, dedicated team
- Take responsibility for your projects
- Work within a flat hierarchy among international team members
We value diversity and therefore expressly welcome all applications - regardless of gender, nationality, ethnic and social origin, religion/belief, physical abilities, age, sexual orientation and identity.
We look forward to receiving your application.