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Regulatory Compliance Manager

vor 2 Monaten

Munich, Bayern, Deutschland ONCARE GmbH Vollzeit

Join a team that is revolutionizing healthcare

At ONCARE GmbH, we are dedicated to transforming the healthcare landscape with our innovative platform, myoncare. Our mission is to provide exceptional healthcare support to patients globally.

Our Approach

We prioritize people in all our endeavors. By connecting various stakeholders within the healthcare ecosystem, we ensure that patients receive timely and appropriate therapies, all while respecting their consent and preferences.

Utilizing audited blockchain technology, myoncare securely collects clinical patient data without direct access, ensuring confidentiality through advanced encryption. For the first time, we have unified previously fragmented patient care functions into a single, comprehensive application.

We are looking for forward-thinkers

As we continue to expand, we seek innovative minds ready to tackle new challenges. Your talent and dedication are crucial to our success, and we invite you to contribute to our mission.

What We Offer

At ONCARE, you will have the opportunity to enhance your problem-solving skills, grow professionally, and engage in meaningful projects that impact the healthcare industry.

Position: Quality and Regulatory Affairs Manager - Healthcare Technology (f/m/d)

Key Responsibilities
  • Assess regulatory requirements to ensure compliance with medical device market standards.
  • Conduct gap analyses of regulatory and quality management system (QMS) documentation, implementing necessary changes.
  • Maintain up-to-date regulatory documentation, including laws, standards, and guidance, ensuring ongoing compliance.
  • Identify and execute regulatory pathways for effective market access.
  • Promote enhancements in QMS processes related to regulatory standards.
  • Manage and update QMS documentation.
  • Provide guidance to departments on regulatory and quality matters.
  • Organize and conduct training sessions for employees.
Qualifications
  • A minimum of three years of experience in Regulatory Affairs for medical devices, preferably in software.
  • At least three years of experience managing QMS in accordance with ISO 13485.
  • Thorough understanding of EN ISO 13485:2016 + AC:2018 + A11:2021, CFR part 820, and relevant FD&C Act sections.
  • Experience in developing and modifying SOPs and Working Instructions in collaboration with departments like R&D and Product Management.
  • Familiarity with Regulatory Affairs in the USA is advantageous.
  • Knowledge of medical device vigilance is a plus.
  • Understanding of ISO 14971, EN 62304, and EN 62366 is beneficial.
  • Ability to work independently with a strong sense of accountability.
  • Proactive in identifying improvement opportunities and providing solutions.
  • Detail-oriented with the ability to adapt quickly to new challenges.
  • Strong communication skills for effective collaboration in international and interdisciplinary teams.
  • Proficiency in English and German, both written and spoken.
What We Provide
  • Competitive salary with opportunities for performance-based advancement.
  • Conveniently located office with various dining options.
  • Tailored onboarding experience.
  • A global team committed to shaping the future of healthcare.
  • Team-building events.
  • Refreshment stations for daily energy boosts.
  • Employee discounts.
  • Networking opportunities with sister companies for professional development.

Be part of the digital transformation in healthcare and take a visionary step into the future with ONCARE GmbH.

We look forward to receiving your application, including your earliest possible start date and salary expectations.

Please review our data protection regulations on our website.