Summary This role is responsible for ensuring that all products comply with applicable global regulatory requirements throughout their lifecycle-from development and registration to post-market surveillance. The Regulatory Affairs Specialist helps ensure regulatory compliance for diagnostics products with FDA, Health Canada, EU, other regulatory bodies, ISO, and business objectives. Essential Duties and 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 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. Qualifications • 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. Preferred Qualifications • 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.