Senior Regulatory Affairs Specialist – Medical Device

Senior Regulatory Affairs Specialist – Medical Device Senior Regulatory Affairs Specialist – Medical Device Get AI-powered advice on this job and more exclusive features. Direct message the job poster from Kaye/Bassman International Experienced Biotech & Pharma & Medical Device Regulatory Affairs & Quality Recruiter | Kaye/Bassman International Position: The Senior Regulatory Affairs Specialist will be responsible for preparing and submitting global regulatory applications in countries such as Japan, India, China, Saudi Arabia, Australia, Mexico, and Brazil. In this role, you will support U.S. Medical submissions by collaborating closely with the Director of Regulatory Affairs. Responsibilities: Filing regulatory submissions 510k, EU MDR, IDEs. Review device labeling (including IFU) and advertising materials for compliance with global regulations; analyze and recommend appropriate changes. Assess design and manufacturing changes for compliance with applicable regulations and effect on global registrations. Maintain regulatory files and tracking databases as needed. Support quality system audits by notified bodies, government agencies, and customers. Obtain Medical Device Certificates to Foreign Government (CFGs). Support post-market surveillance, including preparation of post-market clinical follow-up plans and reports. Participate in the review of complaints and all other post-market-release feedback. Requirements: A bachelor\’s degree in the scientific or engineering field; an advanced degree is preferred. 5-10 years of experience with global regulatory submissions and management of Class II electro-mechanical medical devices. Class II electro-mechanical experience required. Regulatory affairs experience generating applications and expertise in collaboration with internal and external partners to answer subsequent questions. Knowledge of Design Controls and Risk Management practices, regulations, and standards, such as FDA QSR\’s, ISO 13485, ISO 14971, IEC 60601, 60825, and 62366 Experience with lasers and optical technologies is desired but not necessary. Strong working knowledge of Microsoft Word and Excel Seniority level Seniority level Mid-Senior level Employment type Employment type Full-time Job function Job function Strategy/Planning, Product Management, and Science Industries Medical Equipment Manufacturing Referrals increase your chances of interviewing at Kaye/Bassman International by 2x Inferred from the description for this job Medical insurance Vision insurance 401(k) Paid maternity leave Disability insurance Tuition assistance Paid paternity leave Get notified when a new job is posted. Sign in to set job alerts for “Regulatory Affairs Specialist” roles. Regulatory Affairs Specialist, Biologics Regulatory Affairs Documentation Specialist Sr Regulatory Affairs Specialist–Remote Regulatory Affairs CMC Specialist – Contract Regulatory Affairs Specialist – Medical Device Project Specialist, Rates and Regulatory Affairs Quality & Regulatory Specialist (6 mo contract) Bedford, MA $180,000.00-$200,000.00 2 weeks ago Senior Manager, Regulatory Affairs, Operations Regulatory Affairs and Compliance Manager Boston, MA $120,000.00-$125,000.00 3 weeks ago Associate Director, Global Regulatory Affairs Boston, MA $153,600.00-$241,340.00 2 weeks ago Senior Regulatory Affairs Specialist / Regulatory Affairs Manager We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr