Regulatory Affairs Specialist

Direct message the job poster from Intellectt Inc Provide regulatory support for IVD products with multiple product groups with clinical diagnostics. Assembles low to medium complexity regulatory submissions to support worldwide product registration. IVDR Technical file maintenance and monitoring of change requests. Process improvements for SOPs related to full transition to IVDR. Basic analytical, communication, problem solving, and critical thinking skills to meet daily job responsibilities. Interface daily with desktop publisher, technical writers, and regulatory specialists. Work collaboratively with Marketing, R & D, QA, Planning and Manufacturing teams. What You'll Do: Strong prioritization skills, flexibility, and ability to handle multiple projects simultaneously while meeting deadlines Ability to communicate effectively with employees across multiple departments Highly organized and detail oriented. Good time management. Understanding of databases and electronic systems. What we are looking for: Education: BS in Biology or other scientific field 1-2 years experience in IVD regulatory affairs preferred Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Teams) Laboratory research experience in an IVD medical device-regulated environment is strongly preferred. Good knowledge of EU MDR. Understanding of scientific reports, risk management, and Quality Systems Seniority level

Seniority level

Mid-Senior level Employment type

Employment type

Contract Job function

Job function

Manufacturing Industries

Medical Equipment Manufacturing Referrals increase your chances of interviewing at Intellectt Inc by 2x Get notified about new Regulatory Affairs Specialist jobs in

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