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Regulatory R&D Project Manager
Technologie de l'information
Date de début :février 04
Appliquer avant :mars 07 2021
Industrie : Technologie de l'information,
Description du poste
Dice is the leading career destination for tech experts at every stage of their careers. Our client, NetSource, Inc., is seeking the following. Apply via Dice today!
Please note that this is a 1 year contract position. Description We are looking for someone with strong knowledge and experience with the new IVDR regulations. Here are some other considerations Proficient in Project Management Skills for RD Product Development Excellent Communication Skills (Written and Verbal) Advanced Understanding of Product Safety Risk Management and Post Market Surveillance Advanced Understanding of the EU IVDR Regulations and other country regulations Understanding of Performance Evaluation Plans and Reports Understanding of Product Requirements, Specifications and Intended Use Develops and implements programs and processes to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with nationalregionalglobal regulations. Prepares document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements and company policies. Compiles materials required in submissions, license renewal and annual registrations and maintains updated information about nationalregionalglobal regulatory requirements. Proactively manages the changing regulatory environment for company products, prevents barriers to trade, eliminates duplication of effort and identifies and mitigates areas of risk. Reviews product labeling and marketing materials for accuracy and compliance with regulations. Responds to customers andor authorities requestsinquiries dealing with regulations and product compliance Represents company in external bodies dealing with standards andor product regulations at the nationalregionalglobal level. May assess requirements and identify strategies for earliest possible approvals of clinical trials applications. Reduces broad concepts, business strategies into structure projects Leads the design delivery of new programs solutions is the key technical contributor Solves complex, high impact program project design problems Bachelors or Masters Degree or University Degree or equivalent. Typically 8+ years relevant experience for entry to this level. Post-graduate andor certification license may be required. Requires specialized depth andor breadth of expertise in job. Applicants must provide their phone number. Reference Job ID A611.