Regulatory Affairs Manager (m/f/x)

Berlin, Germany
Employee
Healthcare

We are Mika - a VC-financed digital health company based in Berlin. Driven by the vision of improving the well-being and therapy results of cancer patients, we have developed a digital companion for cancer patients: the Mika app. As the leading medical product in the field of patient support and the first DiGA ("App on prescription" in Germany) in oncology, we have a rapidly growing, international team and will expand our service to additional countries and healthcare systems. We are therefore looking for a Regulatory Affairs Manager.

Tasks

In your role as Regulatory Affairs Manager (m / f / x) you will be responsible for the following tasks:

  • Maintain MDR compliance for our medical software (Mika app) as well as DiGAV compliance.
  • Actively work on documentation of the Quality Management System to ensure it stays up-to-date and compliant to ISO 13485.
  • Design smart solutions for new international markets and thereby different legal frameworks in a dynamic regulatory environment.
  • Establish project and process metrics to measure the success and progress of the strategy implementation, identify key areas of opportunity, and drive process improvements.
  • Compile and ensure completeness of the technical file
  • Continuously conduct Risk-Benefit analyses and ensure that all workstreams incorporate a risk management process, interpret these risks in terms of business impact, and ensure appropriate risk responses are in place.
  • Work closely with the Technology & Product Management department in order to meet regulatory requirements and keep senior management team up to date and aware of key risks relating to business.
  • Coordinate with external Data Privacy team of consultants to ensure Data Privacy and Security for our users.
  • Develop and maintain Information Security Management System compliant to ISO 27001.
  • Align with Product and Clinical team on Clinical Evaluation, Claims, Clinical Studies and Post Market Surveillance Requirements and their impact on Technical Documentation and QMS.

Requirements

  • Academic degree (Bachelor/Master/Diplom) in a technical field in combination with (first) regulatory experience in an international company
  • Distinctive (technical) written and verbal communication skills as well as the ability to effectively communicate and collaborate with internal and external stakeholders
  • Ability to read and interpret technical and regulatory documents
  • (First) experiences with the structure of and work in quality management systems (desirable: DIN EN ISO 13485)
  • Knowledge of medical guidance documents, such as MEDDEV
  • Experience as security officer MPG, proportionate "qualified person" or similar functions
  • Familiarity with the European Medical Device Regulation and Harmonized Standards
  • Fluency in English & German is a plus.

Benefits

  • Responsibility in a dynamic, VC-financed digital health company, in which you can make a contribution to improving the situation of cancer patients
  • The chance to shape and internationalize the regualtory affairs of first DiGA in oncology
  • Flat hierarchies, experienced team, attractive remuneration and transparent communication

Does that sound exciting to you? Do you want to be part of a fast-growing company with a vision to improve the lifes of cancer patients with digital support? Then send us your application documents to jobs (at) mitmika. de - We look forward to getting to know you!

Updated: 3 days ago
Job ID: 3395296
About Mika
Driven by the vision to improve the quality of life and therapy outcomes of cancer patients, we provide the Mika app for people affected by cancer.
11-50 employees
Hospital & Health Care
Berlin, Deutschland
Berlin, Deutschland
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Interested?
Documents:
.doc, .docx, .pdf, .rtf, .txt
Contact Person
Darryl Feldman
Darryl Feldman
CPO
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