About this role
Regulatory Affairs Senior Specialist at WSA EMEA. Location: Komorniki, Greater Poland Voivodeship, Poland. Role: shaping strategy, supporting operations, ensuring compliance Requirements: 10+ years regulatory affairs experience in medical devices; strong vigilance and FDA/EU MDR knowledge; experience with medical device software/SaMD; MSc preferred; documented EU MDR, ISO 13485 and ISO 14971 training. Category: Legal and Compliance Seniority: Senior Level Certifications: eu mdr 2017/745, iso 13485, iso 14971 Commitment: Full Time Workplace: Onsite Languages: English