Senior IVD Regulatory Affairs Specialist 12 month contract position with a strong chance of extending for 3 years and/or converting to a permanent employee. Large, international medical device company who is growing and increasing their business. Day shift typically working from 8:00 am - 5:00 pm. This is a top notch company with a bright team working on advancing technologies! Fabulous facility with many amenities. Looking for Senior IVD Regulatory Affairs Specialist with In vitro diagnostics reagent product development experience (or related experience). Applies extensive and diversified knowledge of design control principles and practices and regulations in support of new product development. General responsibilities include review of scientific protocols and reports to support the development of new in vitro diagnostic tests. Documents are reviewed to assess performance against product requirements, design specifications and regulatory compliance/risk. Additionally the candidate will participate in study design, technical reviews, facilitates product risk assessment, and support regulatory filings. The candidate will review stability data, design control deliverables, and clinical study reports. Responsible for ensuring that new and existing products and processes deliver safe and effective medical devices. You will be embedded within various collaborative research groups within the company to give them direction and guidance. Excellent written and verbal communication is needed. ESSENTIAL FUNCTIONS: Assures quality through the review of development documentation for sound experimental design, accuracy and completeness. Provides guidance on design control practices to cross functional technical teams. Provides technical feedback to others. Ensures compliance with and mentors in the use of company policies and procedures. Receives general direction and exercises considerable discretion as to work details. Committed to timely achievement of overall project goals. Identifies and implements improvements to work processes. This role requires the ability to make independent decisions. Monitors work to ensure quality, and continuously promote Quality First Time.
Knowledge, Skills and Abilities: Need IVD reagent and medical device development understanding, partnered with Design Control regulations. Extensive knowledge of applicable regulations and standards, including 21 CFR Part 820, IVDD 98/79/EC, ISO13485 and ISO14971. Experience utilizing Design Control principles and concepts in new product development. Demonstrates success in collaboration with others, effective communication and decision making.Formal Training/Education: BS/MS Biochemistry or related discipline. Advanced studies or training. Experience: Typically requires a minimum of 8 years of related experience.