Quality and Regulatory Affairs Manager - Healthcare Technology fmd

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 and Regulatory Affairs Manager Healthcare Technology (f/m/d).

Tasks

• Identify regulatory requirements to reach compliance to market requirements for medical devices
• Perform gap analyses of regulatory documents and QMS documentation derive and implement required adaptations in documentation and processes
• Keep regulatory documentation such as laws standards regulations and guidance documents uptodate and ensure continuous compliance of QMS and product to these requirements
• Identify and execute regulatory pathways for successful market access
• Actively promote improvement in QMS processes related to regulatory requirements
• Administration and maintenance of the QMS documentation
• Advise specialist departments in daily regulatory and qualityrelated activities
• Plan and perform employee trainings

Requirements

• At least three years of experience in Regulatory Affairs for medical devices ideally of medical device software
• At least three years of experience in managing QM systems covering ISO 13485
• Indepth knowledge of EN ISO 13485:2016 AC:2018 A11:2021 CFR part 820 and relevant sections of the FD&C Act
• Experience in generating and adapting SOPs and Working Instructions together with specialist departments such as Research & Development and Product Management
• Experience in Regulatory Affairs in USA markets beneficial
• Experience in medical device vigilance beneficial
• Knowledge of ISO 14971 EN 62304 and EN 62366 beneficial
• Independent working and a strong sense of responsibility for your own actions
• Drive to identify potential for improvement and to find solutions for stakeholders
• Thoroughness in everything you do a great attention to detail and the ability to quickly adapt to new problems even on tight schedules
• Effective communication in international and interdisciplinary teams and active listening skills
• Excellent English and German proficiency (written and spoken)

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.