Quality Manager with focus on Clinical Affairs fmd
Location
München | Germany
Job description
We are status quo breakers game changers and pathway makers!
With our health platform myoncare we are transforming the healthcare market and as a leading ecosystem we want to enable excellent healthcare support for all patients in the world.
How do we do that
People are at the center of everything we do!
We connect all the players in the healthcare system to ensure that patients receive the right therapy at the right time and to the right extent. All with the commitment and consent of the patient.
Myoncare collects clinical patient data thanks to audited blockchain without its own access and ensures its security through encryption. For the first time all patient care functions that previously existed as individual solutions or in incomplete form are bundled into one application!
We have big plans today and tomorrow! And thats why we are looking for innovators changemakers and minds that are ready to take on new challenges.
Talent and commitment are the key and thats why we need YOU! Come join the team and help us realise our mission.
Myoncare offers you a space to flex your problemsolving muscles develop and expand your skills and work on projects that really matter so you can grow with us.
Experience the digital revolution of the healthcare system first hands as our new Quality Manager with Focus on Clinical Affairs (f/m/d).
Tasks
- Take ownership of the clinical evaluation process and ensure the proper planning and execution of the activities associated with it.
- As author of CDP CEP CER and other relevant documents you ensure that clinical evaluation records are maintained according to the stateoftheart and are kept uptodate.
- Take coownership of the postmarket surveillance process plan conduct and document PMS activities including PMCF.
- Continuous improvement of the processes and the documentation associated with Clinical Affairs and their smooth integration in the QMS are a given to you.
- As a subject matter expert in clinical affairs you work closely with interdisciplinary experts in the company and support in audits and external queries.
- Review QMS and technical documentation relating to clinical data marketing claims PMS activities and risk management.
- As Quality Manager you perform gap and/ or impact analysis for changes to the QMS and carry out the change planning and the implementation.
- You further support and contribute to QMS processes regarding supplier evaluations software tool validation and CAPA handling.
Requirements
- University degree in medicine life sciences medical engineering or related fields.
- 3 years of experience as a Quality Manager in the medical device field with at least 2 years of experience in Clinical Affairs of a medical device.
- Proven knowledge in research methodology including clinical investigation design information management and research using databases.
- Knowledge in statistical analysis and trending.
- Proven knowledge in regulatory requirements of medical devices in particular pertaining to clinical evaluation risk management and postmarket surveillance in the EU other markets is a plus.
- Proven expertise in medical writing e.g. postgraduate experience in science or medicine training in medical writing handson professional experience.
- Knowledge of the medical device sector (ISO 13485 Regulation EU 2017/745) is a must.
- Good Documentation Practices are in your blood and you know how to express complex issues in a precise and readily understandable manner.
- Analytical and resultsoriented working attitude.
- High work ethics attention to detail and due diligence in everything you do.
- You have excellent communication skills and are fluent in English (Verbal and written). German is a plus.
- Experience with SaMD / MDSW and SDLC is a plus.
Benefits
- We always work with a permanent contract as we would like to keep you on our team as long as possible.
- A modern and comfortable office in the heart of Munich.
- A structured onboarding tailored to your needs as we want each individual to arrive at our company the best possible way both personally and professionally.
- An international helpful highly motivated and agile team.
- Professional and personal development opportunities and the best career prospects due to our strong expansion.
- Various team events to constantly improve cohesion.
- The possibility of mobile work to create the best possible work/ life balance for you.
- A flexible working time model.
- Free coffee and tea to sweeten your working day.
- Lightning talks and regular gettogethers to keep our team up to date with the latest developments.
- Very good connection to public transportation.
- Variety of lunch options in the area restaurants supermarkets etc.
- Constructive exchange and connection with the sister companies CONVIEN GmbH (CO2 reduction) and sqanit GmbH (service platform).
Our core values:
Trust technology We are committed to creating a safe and sound environment for digital health. Were setting standards in data security because we know that in order for people to trust technology there needs to be reliable solutions by disruptive technology.
Collaborative mindset We know we only can tackle complexity together. We focus on our strengths and build on synergies. Because we know connected solutions lead to simplified and better healthcare.
Adaptive thinking We do not believe in one fits all solutions because we know the reality is different. We easily adapt to changing conditions by providing modular and scalable solutions for a complex and everchanging ecosystem.
Human innovation We are transforming healthcare for the sake of the people. By putting patients at the centre of our doing we ensure a holistic and sustainable view of healthcare.
Contribute to the digitalization of healthcare and take visionary step into the future with us!
Become part of the ONCARE family and apply today with your complete application documents stating your earliest possible starting date and your salary expectations.
We are looking forward to hearing from you!
Please not our data protection regulations on our homepage.
Job tags
Salary
