Quality and Regulatory Affairs Lead
Vor 7 Tagen
**Join OnlineDoctor: We're Expanding**
We are a fast-growing telemedicine startup focused on improving access to dermatological care. Our platform uses cutting-edge technology to connect patients with dermatologists, enabling them to take pictures of their skin issues and receive diagnoses and treatment plans remotely and asynchronously. We're looking for a talented Quality and Regulatory Affairs Lead to join our team and help us continue to innovate and expand our platform.
**Responsibilities**:
- **ISO 13485 & QMS Management**: Maintain and streamline the QMS, ensuring efficient and compliant processes within the organization. Specifically ensure compliant lifecycle management of medical software products.
- **Audit & Regulatory Communication**: Lead internal and external audits, serve as the primary point of contact for authorities and notified bodies, and ensure audit readiness.
- **Risk Management**: Oversee risk management processes per ISO 14971 and 24971, integrating these into development and product lifecycle workflows.
- **Compliance Oversight**: Ensure compliance with EU MDR, MDD and relevant standards, including IEC 62304 and 62366, for software as a medical device.
- **Process Improvement**: Challenge and refine existing tooling and processes to maintain high-quality standards while balancing resource constraints.
- **Collaboration**: Work closely with internal teams and external consultants to align QMS and regulatory processes across the organization.
- **Training and Advocacy**: Actively train and mentor teams on quality and regulatory best practices.
- **Stakeholder Communication**: Effectively engage with healthcare professionals to ensure product alignment with end-user needs.
**Requirements**:
- Minimum of 5 years at a medical device manufacturer or consultancy.
- Proven experience bringing medical devices to market under MDD or MDR.
- University degree in biomedical sciences, engineering, pharmacy, or related natural sciences.
- In-depth understanding of ISO 13485, ISO 14971
- Ideally in-depth understanding of IEC 62304, and 62366.
- Experience managing risk and regulatory processes.
- Demonstrated ability to oversee and refine QMS systems for seamless organizational use.
- Strong analytical and decision-making skills with a resource-aware mindset.
- Proficient knowledge of EU medical device regulations and quality management practices.
- Fluency in English; proficiency in German is a significant advantage.
**Bonus**:
- Familiarity with software development aligned with IEC 62304.
- Hands-on MDR product experience.
**What we offer**:
- **Flexibility**: You decide if you want to work remote or if you prefer to visit one of our Offices (Hamburg, St. Gallen, Zürich). We offer you a flexible schedule and a working time model that suits you.
- **Learning culture**: We offer you a steep learning curve in your daily work and support you in your personal and professional development through regular retro and inspiration sessions as well as advanced training. We are open for ideas and impulses and help you with the implementation.
- **Team events**: Skiing in Switzerland, white water rafting in Vienna - we regularly get together with our entire team and thus increase our teamwork.
- **Fair salary**: An attractive salary is a matter of course for us.
- **Additional benefits**: Free choice of laptop, home office allowance, additional vacation day, etc.
- Individual training budget for every employee to support personal and professional development
- **Our Values**:Respect and tolerance are part of our DNA. We actively support diversity and inclusion, believing they are the keys to a successful and healthy company culture.
Ready to Join Us?
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