We are hiring the following positions at the moment
QM and RA Specialist (m/w/d)
As part of our Quality and Regulatory team, you will be responsible for ensuring that our Quality Management System (QMS) is compliant with ISO 13485 and the Medical Device Regulation (MDR) amongst others. This role requires a deep understanding of medical device regulations, standards, and best practices as well as a willingness to set new standards as we are the leading provider of AI in musculoskeletal diagnosis support.
- Quality Management: Maintain and enhance the quality management system.
- Team Support: Aid in crafting efficient processes and workflows.
- Audit Management: Prepare and support both internal & external audits.
- Compliance Oversight: Ensure adherence to national, EU, and U.S. regulations.
- Risk Management: Establish and uphold risk management company-wide.
- Change Management: Assist process owners in quality system modifications.
- Authority Communication: Liaise with Notified Bodies and competent authorities.
- Team Development: Empower the teams across the company to achieve their potential.
- Continuous Improvement: Drive technological and process advancements.
- Product Development: Prioritize quality from product inception.
- Regulatory Compliance: Monitor updates and guarantee product compliance.
- Passion: Driven by a mission to enhance healthcare outcomes.
- Educational Background: Bachelor's in Biomedical Engineering, Regulatory Affairs, or related field.
- Experience: 3-5 years in quality management and regulatory affairs in the medical device sector.
- Expertise: Proficient in ISO 13485, MDR, and other pertinent standards.
- Analytical Prowess: Possess strong problem-solving skills.
- Communication: Exhibit excellent interpersonal and communication abilities.
- Certifications: Regulatory affairs or quality management certification (e.g., internal auditor) is advantageous.
- Commitment: Willing to work extended hours during crucial project stages. Celebrate success with the team.
The official company language is English, therefore, a working knowledge of English is required.
What we offer
Joining ImageBiopsy Lab as a young QM professional offers a unique blend of learning, growth, and the opportunity to make a significant impact in the field of musculoskeletal imaging diagnostics.
- Exciting Work Environment: Engage in aninternationally growing Health-AI start-up.
- Innovation and Learning: Delve into the latestin AI-driven medical imaging.
- Cross-functional Collaboration: Collaboratefrom R&D to marketing.
- Impact on Patient Care: Uphold product qualityand safety standards.
- Professional Growth: Embrace challenges andevolve as an industry leader.
- Global Impact: Understand regulatory nuancesacross countries.
- Leadership Opportunities: Ascend to pivotalroles within the QM team.
- Employment Flexibility: Opt for full-time orpart-time roles at Vienna HQ.
- Challenging Tasks: Take personalresponsibility for projects and tasks.
- Education Opportunities: Access internal andexternal education programs.
- Competitive salary:starting from 2,500 € / month gross. Increased depending on qualifications and experience.