About This Role
This Regulatory Affairs Specialist role ensures that all products comply with applicable global regulatory requirements throughout their lifecycle, from development and registration to post-market surveillance. The specialist helps ensure regulatory compliance for diagnostics products with the FDA, Health Canada, EU, other regulatory bodies, ISO, and business objectives.
Responsibilities
- Implement company regulatory affairs procedures
- Prepare, compile, and submit regulatory documentation (e.g., 510(k), PMA, CE Technical Files) to global regulatory agencies and, with guidance from the Regulatory Affairs Manager, manage regulatory submissions
- Interpret and apply FDA, EU MDR, ISO 13485, and other international regulations to ensure product compliance
- Collaborate with cross-functional teams (R&D, Quality, Clinical, Marketing) to support product development and regulatory strategy
- Review and approve product labeling, instructions for use (IFUs), and promotional materials for regulatory compliance
- Monitor and analyze changes in regulatory requirements and communicate updates to internal stakeholders
- Support internal and external audits, including FDA inspections and Notified Body assessments
- Maintain regulatory files and databases, ensuring accurate and up-to-date documentation
- Participate in post-market surveillance activities, including adverse event reporting and field actions
- Provide regulatory input during risk assessments and design control processes
Requirements
- Bachelor's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field
- 2–5 years of experience in regulatory affairs, preferably in the medical device industry
- Strong understanding of FDA regulations (21 CFR Part 820), EU MDR, and ISO 13485
- Experience with regulatory submissions and product registrations in multiple global markets
- Excellent written and verbal communication skills
- Strong organizational and project management abilities
Nice to have:
- RAC certification (Regulatory Affairs Certification)
- Experience with electronic submission systems (e.g., eSTAR, EUDAMED)
- Experience with MDSAP, ISO 14971 (risk management), and clinical evaluation reporting
