About the Role
The specialist will manage regulatory submissions, maintain documentation, and collaborate across departments to ensure timely approvals and compliance with international regulations.
Responsibilities
- Prepare and submit regulatory dossiers for product approvals in global markets
- Ensure compliance with regional and international regulatory requirements
- Collaborate with cross-functional teams including quality, legal, and R&D
- Track and interpret changes in regulatory policies affecting product development
- Maintain up-to-date regulatory databases and product registration records
- Support audits and inspections by regulatory authorities
- Coordinate responses to agency queries during review processes
- Assist in labeling and promotional material reviews for regulatory compliance
- Manage timelines for submission deliverables across multiple regions
- Provide regulatory input during product lifecycle changes
- Oversee post-market regulatory obligations and reporting
- Work with external agencies and consultants as needed
- Develop and deliver regulatory training to internal stakeholders
- Maintain familiarity with evolving medical device regulations
- Support new product development with early-stage regulatory strategy
- Ensure consistency in regulatory documentation across submissions
- Participate in internal review boards for product changes
- Monitor competitor regulatory activity and market trends
- Assist in harmonizing regulatory approaches across regions
- Document regulatory justifications for non-clinical and clinical data
- Support product classification and regulatory pathway determination
- Maintain records in compliance with document retention policies
- Contribute to process improvement initiatives in regulatory operations
- Ensure accurate translation of regulatory content for international use
- Participate in regulatory intelligence gathering and reporting
Compensation
Competitive salary and benefits package offered
Work Arrangement
Hybrid work model with partial remote and on-site presence
Team
Part of the global regulatory affairs team within a multinational medical technology organization
Why Join Us
- Opportunity to contribute to life-enhancing medical technologies
- Work in a culture that values innovation, integrity, and collaboration
- Access to professional development and growth opportunities
- Be part of a company committed to improving healthcare outcomes globally
Equal Opportunity Employer
We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, or protected veteran status
Limited visa sponsorship may be available for qualified candidates
