Now Hiring: Regulatory Affairs Associate II We are seeking a Regulatory Affairs Associate II to support medical device regulatory activities , with a strong focus on EU MDR compliance . This role plays a key part in ensuring regulatory readiness and successful submissions across global markets. Minimum Qualifications Preferred: Pharmacy, Biology, Chemistry, Pharmacology, Engineering, or a related field Candidates should have experience with: Medical Device Regulatory Affairs EU MDR remediation activities Regulation (EU) 2017/745 Technical Files / Technical Documentation GSPR (General Safety & Performance Requirements) 510(k) submissions Interaction with FDA and/or Notified Bodies ISO 13485 Quality Management Systems EU MDR compliance initiatives What You’ll Do Support preparation and maintenance of EU MDR Technical Documentation Assist with regulatory submissions and remediation projects Collaborate with cross-functional teams to ensure compliance Interface with regulatory authorities as needed Interested candidates or referrals are encouraged to apply. #J-18808-Ljbffr