Job Summary
The Regulatory Affairs Specialist supports regulatory strategy and submission activities for medical device products. This role ensures compliance with global regulatory requirements and assists in preparing documentation for product approvals and lifecycle management within the Medical Device Industry.
Key Responsibilities
- Prepare and submit regulatory documentation for product approvals and changes
- Support regulatory submissions such as 510(k), technical files, and regulatory reports
- Maintain regulatory documentation and product registrations
- Monitor regulatory requirements and ensure compliance with applicable standards
- Collaborate with quality, engineering, and clinical teams on regulatory activities
- Assist in responding to regulatory authority inquiries and audits
- Track submission timelines and regulatory project milestones
- Support post-market regulatory compliance activities
Job Qualifications
- Bachelor’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or related field
- 3–5 years of experience in regulatory affairs within medical devices
- Knowledge of global medical device regulations and submission processes
- Experience preparing regulatory documentation and technical files
- Strong attention to detail and regulatory compliance understanding
Skills / Tools
- FDA 510(k)
- ISO 13485
- EU MDR
- Regulatory submission management systems
- Document control and quality management systems (QMS)
