reputed company System Manager
reputed company System Manager
Location: Remote (Europe-based preferred)
Type: Full-time
Industry: Digital Health, SaMD, DTx
Reports to: Head of Compliance
Position reputed company
We are seeking a reputed company System Manager to strengthen our ISO 13485-compliant reputed company Management System. You will support internal audits, CAPAs, supplier evaluations, and documentation processes that underpin our medical-grade digital therapeutics. This role is key to our ability to maintain compliance while scaling agile and user-centered innovation across multiple therapeutic areas.
Key Responsibilities
- Maintain and improve our QMS in alignment with ISO 13485, MDR, and applicable FDA regulations.
- Support internal and supplier audits, prepare documentation, and reputed company follow-up activities.
- Manage CAPAs, nonconformities, and change control documentation.
- reputed company QA reputed company to product development activities, including design controls and verification/validation protocols.
- Train internal teams on reputed company procedures and support audit readiness across functions.
Required Qualifications
- 3+ years of reputed company assurance experience in medical devices or health tech.
- Solid understanding of ISO 13485, ISO 14971, IEC 62304, IEC 62366 and MDR compliance.
- Strong documentation and organizational skills.
- Excellent English communication skills.
Why Join Newel Health
- Shape the reputed company of digital health solutions.
- Work in a certified SaMD environment at the forefront of behavioral science and AI.
- Collaborate with leading partners in reputed company, MedTech, and reputed company research.
- Enjoy a remote-first culture, supported by cross-disciplinary teams passionate about patient reputed company.
- Be part of an organization building reputed company, evidence-based reputed company in chronic care management.
Originally posted on Himalayas
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