Quality Manager with ISMS Knowledge - Heathcare Technology (f/m/d) at ONCARE GmbH

Munich, Bavaria, Germany -

Full Time

Start Date

Immediate

Expiry Date

21 Dec, 25

Salary

0.0

Posted On

22 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Quality Management Systems, ISO 13485, MDR 2017/745, CFR Part 820, SOPs, Medical Device Vigilance, ISO 14971, ISO 27001, Attention To Detail, Time Management, Effective Communication, Problem Solving, Employee Training, ISMS, Adaptability

Industry

IT Services and IT Consulting

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 that's why we are looking for innovators, change-makers and minds that are ready to take on new challenges. Talent and commitment are the key and that's why we need YOU! Come join the team and help us realise our mission. Myoncare offers you a space to flex your problem-solving 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 Senior Quality and Regulatory Affairs Manager - Healthcare Technology (f/m/d). Tasks 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 up-to-date 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 Administration and maintenance of the QMS documentation Advise other departments in daily regulatory and quality-related activities Plan and perform employee trainings Maintaining and continuously improving the ISMS in accordance with ISO/IEC 27001 Ensuring the smooth integration of ISMS processes with other QMS processes Requirements At least three years of experience in Regulatory Affairs or Quality Department for medical devices, ideally of medical device software At least three years of experience in managing QM systems covering ISO 13485 In-depth knowledge of MDR 2017/745, EN ISO 13485:2016, CFR part 820 and relevant sections of the FD&C Act Experience in generating and adapting SOPs and Working Instructions together with respective 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 Good ISO 27001 Knowledge Certificate as internal auditor for ISO 13485 and ISO 27001 are a major plus 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 Excellent time management and organizational skills Effective communication in international and interdisciplinary teams and active listening skills Excellent English proficiency (written and spoken), German proficiency is beneficial Benefits Competitive salary with performance-based growth Central located office with plenty of lunch options Personalized onboarding experience Global team shaping the future of healthcare Team events Coffee and tea stations for daily recharge Employee discounts Networking opportunities with sister companies (sqanit & CONVIEN) for professional growth 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.

Responsibilities

The Quality Manager will perform gap analyses of regulatory documents and QMS documentation, ensuring continuous compliance and promoting improvements in QMS processes. They will also maintain ISMS in accordance with ISO/IEC 27001 and advise other departments on regulatory and quality-related activities.