Vara - Senior Regulatory Affairs Expert

Merantix (Berlin, Deutschland) Vor 8 Tagen veröffentlicht

Are you passionate about technology and healthcare? Are you excited about taking ownership of strategic projects? Do you want to play a key role in bringing safe and cutting-edge AI applications into clinical practice? Do you want to work on meaningful tasks and have an impact? 


We are looking for a dedicated and conscientious Regulatory Affairs Expert to extend our team and to help us build the next generation of deep learning applications for the global healthcare market.

Our ideal candidate can demonstrate a successful track record in start-up and regulatory environments; is thorough and solution-oriented; well-organized, collaborative and finds purpose in healthcare. 


What we do

Vara improves breast cancer screening with its Artificial Intelligence-based workflow platform. The Vara algorithm has been developed on one of the world's largest breast cancer datasets for the last two years and has the potential to significantly speed up the screening process while preventing missed cancers.


The Vara team is made up of 25 entrepreneurs, researchers, medical doctors, and engineers from top-tier companies (e.g. Google, Amazon, BCG) and universities (e.g. Oxford, Stanford, University of St. Gallen) around the world. We’re based in Europe’s startup capital, Berlin, and growing quickly!


Your Job

  • Shape company quality culture and processes together with C-level Management:
    • Define new processes, monitor existing ones and implement changes where necessary in coordination with other workstreams;
    • Observe and implement process requirements in critical company functions from software development to supplier management;
    • Coordinate strategic questions with external lawyers or advisors and provide the point of contact for internal quality control.
  • Become a mastermind of our quality management system:
    • Keep yourself updated with latest legal provisions in the field of artificial intelligence and medical device regulation (e.g. MPG, ISO 13485), analyze and address applicable regulation within our quality management system;
    • Control document and record management to prepare and conduct audits;
    • Manage corrective and preventive actions (CAPA) and key performance indicators of our QMS as input for management review.
  • Take ownership for our medical device, manage relationships with regulatory stakeholders:
    • Plan new product features and compile technical documentation for new versions of our software;
    • Support continued risk management and post-market surveillance activities for Vara;
    • Liaise with state authorities and Notified Body for product submission and registration
  • Value data privacy of our customers and patients:
    • Take responsibility as the data protection officer of our company and provide the point of contact for internal and external questions on data privacy and IT-security


Your Profile

Basic qualifications:

  • Excellent verbal and written communication in both English and German
  • A minimum of 5 years experience in regulatory affairs for medical devices; with the EU General Data Protection Regulation (GDPR), EU Regulation 2017/745 and ISO 13485:2016
  • Higher education degree (B.A., M.A.) in business, computer science or other relevant subject
  • Strong sense for responsibility, diligence and accuracy on a daily basis
  • High organizational skills: strategic and systematic approach to take purposeful action
  • Goal-oriented and pragmatic mindset to balance requirements for compliance and agility, inventing smart solutions in new regulatory environments
  • Perseverance and resilience to constantly improve the daily work of our company
  • Willingness to take responsibility and independent working style as well as the ability to achieve goals collaboratively


The preferred qualifications are just that: preferred. None of us walked in with all of them. If a few of these points apply to you, we definitely want to talk!


Preferred qualifications:

  • Qualification or prior experience as a Data Protection Officer (DPO) acc. to Art. 37 and 39 GDPR
  • Prior experience with ISO 27001, U.S. HIPAA regulation and FDA 21 CFR part 820
  • Prior experience in programming and basic technical understanding


What We Offer

  • We believe in personal ownership, flat hierarchies and direct communication, which means that we operate and learn fast – as a team;
  • We encourage a dynamic, results-oriented working environment: work from the office and/or balance your time working from home; 
  • We are driven researchers, developers and entrepreneurs who believe in building transformative solutions our customers can’t live without;
  • We encourage our employees to continuously develop their skills at conferences, workshops, seminars or through other methods;
  • We have regular off-site and team dinners;
  • We are an equal-opportunity employer and value broad diversity. We consider all applications equally, and can help with immigration.



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