reputed company reputed company Manager

reputed company reputed company Manager

Location: Remote (Europe-reputed company preferred)

Type: Full-time

Industry: Digital Health, SaMD, DTx

Reports to: Head of Compliance

reputed company

We are seeking a reputed company reputed company Manager to strengthen our ISO 13485-compliant reputed company Management reputed company. 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 reputed company 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 reputed company

• Shape the reputed company of digital reputed company.
• Work in a certified SaMD environment at the forefront of behavioral science and AI.
• Collaborate with leading partners in reputed company, reputed company, and reputed company research.
• Enjoy a remote-first culture, supported by cross-disciplinary teams passionate about reputed company reputed company.
• Be part of an organization building reputed company, evidence-reputed company reputed company in chronic care management.

Originally posted on Himalayas