About the Role
The Regulatory & Quality Documentation Specialist ensures accurate and compliant documentation throughout the product lifecycle, supporting regulatory submissions, audits, and quality system requirements for medical devices.
Responsibilities
- Prepare, review, and maintain regulatory and quality documents for medical devices
- Ensure documentation complies with applicable regulations and internal procedures
- Support submissions to regulatory authorities by compiling required documentation
- Manage document control processes including versioning, approvals, and archiving
- Assist in internal and external audits by providing accurate documentation
- Track and report on document metrics and compliance status
- Collaborate with cross-functional teams to gather technical content
- Maintain up-to-date knowledge of regulatory requirements
- Review product labeling and packaging documentation for compliance
- Support change management processes related to documentation updates
- Ensure records are maintained in accordance with data retention policies
- Participate in continuous improvement initiatives for documentation systems
- Assist in training team members on document control procedures
- Monitor regulatory updates impacting documentation standards
- Coordinate with external partners on documentation deliverables
- Maintain document templates and formatting standards
- Verify accuracy and completeness of technical files
- Support quality management system audits and inspections
- Manage electronic document management system records
- Ensure traceability between regulatory submissions and internal documents
- Facilitate timely document approvals through defined workflows
- Identify gaps in documentation and initiate corrective actions
- Maintain confidentiality and integrity of sensitive documentation
- Support product lifecycle documentation from development to commercialization
- Contribute to process optimization for documentation efficiency
Compensation
Competitive salary based on experience and qualifications
Work Arrangement
Hybrid work model with a combination of on-site and remote days
Team
Part of the Quality & Regulatory Affairs team, collaborating with cross-functional departments including R&D, Manufacturing, and Clinical Affairs
Why Join Us
- Opportunity to work in a growing organization with a focus on innovation
- Supportive environment that values professional development
- Exposure to international regulatory markets
- Collaborative culture with cross-functional engagement
- Investment in employee well-being and work-life balance
What We Offer
- Competitive compensation and performance-based bonuses
- Comprehensive health insurance package
- Flexible working hours and hybrid model
- Professional training and certification support
- Modern office facilities with ergonomic workspaces
- Employee recognition programs
- Wellness initiatives and mental health support
- Team-building activities and social events
- Sustainable commuting incentives
- Opportunities for career advancement
Available for qualified non-EU candidates
