About the Role
The role involves managing regulatory submissions, guiding cross-functional teams through compliance requirements, and maintaining alignment with international medical device regulations.
Responsibilities
- Lead the development and execution of regulatory strategies for medical device product lines
- Prepare and submit regulatory dossiers to health authorities across multiple jurisdictions
- Ensure compliance with FDA, CE, and other regional regulatory standards
- Interpret evolving regulatory guidelines and implement necessary changes
- Collaborate with quality assurance and clinical teams to align documentation
- Manage interactions with notified bodies and regulatory agencies
- Oversee labeling and technical file maintenance in accordance with regulations
- Guide product lifecycle management from development through post-market surveillance
- Maintain up-to-date knowledge of global regulatory trends and requirements
- Support audits and inspections by regulatory bodies
- Develop and maintain regulatory project timelines and submission plans
- Ensure compliance with ISO 13485 and related quality management standards
- Assist in risk assessment and classification of medical devices
- Coordinate with external consultants and testing laboratories
- Train internal teams on regulatory expectations and updates
- Monitor changes in regulatory policies affecting product approvals
- Lead responses to regulatory inquiries and deficiency letters
- Ensure proper documentation for design controls and change management
- Support international expansion by navigating country-specific requirements
- Maintain regulatory intelligence database for key markets
Compensation
Competitive salary and benefits package
Work Arrangement
Full-time, remote position with flexible hours
Team
Cross-functional team focused on medical device innovation and compliance
Why This Role Matters
This position plays a critical role in bringing safe and effective medical technologies to patients worldwide by ensuring all regulatory requirements are met efficiently and accurately.
Growth Opportunities
The specialist will have the chance to shape regulatory processes, influence product development, and contribute to scaling operations in new markets.
Available for qualified candidates
