Regulatory Affairs Manager (f/m/x)
Berlin, Germany
Full time
Our vision/goal
AssistMe is a young, digital smart care company based in Berlin. We develop future-proof solutions in the field of digital health and care technology. We support the nursing industry on its way to raising the quality of its work to a new level.
AssistMe is a young, digital smart care company based in Berlin. We develop future-proof solutions in the field of digital health and care technology. We support the nursing industry on its way to raising the quality of its work to a new level.
Our IoT system notifies nursing staff in real time about critical care events such as incontinence, falls and more. Our goal is to equip nursing staff with efficient, effective tools and help improve the quality of care for all.
Shape the future of smart care with us!
The position
As our Regulatory Affairs Manager, you take responsibility for the approval strategy and its implementation at AssistMe. This is a central function for the future of the company and you will help to meet the relevant national and international regulatory requirements. You will work closely with our product managers, marketing and technical managers to make important product and go-to-market decisions.
Job requirements
Your tasks:
- Setup, documentation and maintenance of the AssistMe quality management system, which covers all departments (product development, technology, QA, marketing, sales, administration, HR, etc.)
- Management of our certification process for medical devices and monitoring ongoing compliance with medical software regulations in the EU (CE, MDR) and preferably also in the USA (FDA)
- Up-to-date on current regulatory developments in the countries or regions in which we distribute our products or services
- Ensure that the QMS complies with the common standards (ISO13485, 21 CFR Part 820) by setting up and carrying out the necessary audits by notified bodies to obtain certification
- Creation and maintenance of the technical documents required for MDR certification. Identification of the regulations that the devices must comply with and preparation of the necessary test plans
- Development and maintenance of the risk management dossier in accordance with ISO 14971 and development of a strategy for the mitigation of identified risks and to prove the effectiveness of the solution as well as the introduction and maintenance of the information security management system (ISMS) in accordance with ISO 27001
- Building relationships with external actors, e.g. B. to the competent authority responsible for compliance with Article 15 of the MDR.
Your qualifications:
- min. 3 years of professional experience in the field of strategy, classification and introduction of medical devices, preferably in the areas of hardware, firmware and software services and knowledge of all applicable standards in the EU and preferably also in the USA
- Experience with device certification (IEC60601) and quality management systems according to ISO 13485, preferably also according to 21 CFR part 820
- Ability to design regulatory processes in close cooperation with hardware and software development, clinical and business teams
- Excellent written and spoken communication skills in German and English
- A very practical approach and the ability to work in a dynamic start-up culture
Ideally, you have:
- A university degree in a relevant field such as law, medicine, pharmacy, computer science, engineering or any other scientific discipline
- The ability to adapt and thrive in a fast-paced start-up environment, as well as the willingness to iterate existing structures and new concepts
- Proven experience in the market launch of new, innovative products
- The ability to deliver results and a high tolerance for ambiguity
Your benefits:
- Agile teamwork
- Permanent full-time employment contract
- Individual training opportunities
- Flat hierarchies and short decision-making paths
- New office & Tech Lab in Berlin Mitte
How to apply
Please follow the link provided to access and complete the application form.
We value diversity and therefore expressly welcome all applications - regardless of gender, nationality, ethnic and social origin, religion/worldview, physical abilities, age as well as sexual orientation and identity.
We value diversity and therefore expressly welcome all applications - regardless of gender, nationality, ethnic and social origin, religion/worldview, physical abilities, age as well as sexual orientation and identity.
We look forward to receiving your application!
AssistMe
AssistMe researches and develops technical solutions for the medical, care and health sectors to enable elderly people and those in need of care to...
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