Vi söker Seniora QA/RA Medtechkonsulter
Core
Senior consultant providing regulatory and quality assurance support for medical device and in-vitro diagnostic product development, focusing on strategy, documentation, and compliance.
Role type
Senior Regulatory & Quality Consultant (Medical Devices)
Builds
Regulatory strategies, management systems, and technical documentation for medical device companies.
Domain
Medical Technology / Regulatory Affairs / Quality Management
Deliverable
client delivery
Required skills
Regulatory strategy (EU, UK, Switzerland, USA), Quality management systems, CAPA handling, Supplier evaluation, Biocompatibility assessment, Clinical evaluation planning and reporting
Preferred skills
Prior consulting experience, Team collaboration
Technologies
None stated
Responsibilities
Develop regulatory strategies for target markets; Support development of management systems and technical documentation; Manage quality processes including CAPA and supplier evaluation; Interact with testing houses, authorities, and stakeholders during product approval.
Seniority
Senior, hands-on IC
