REGULATORY AFFAIRS SPECIALIST I - HEART FAILURE (ON-SITE)

R&D Partners is seeking to hire a Regulatory Affairs Specialist II in Lake Forest, CA. Your main responsibilities as a Regulatory Affairs Specialist II: Compile and maintain regulatory documentation databases or systems. Coordinate efforts associated with the preparation of regulatory documents or submissions. Analyze product complaints and make recommendations regarding their reportability. Develop or conduct employee regulatory training. Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review. What we are looking for in a Regulatory Affairs Specialist II: 3-5 years of work experience Knowledge of US, EU, and Canada Medical Device Regulations Familiarity with PLM WindChill and Veeva RIM platforms (not a mandatory requirement) Salary: $99,611 - $122,283 (Dependent on Experience) R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

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