Regulatory Affairs Specialist - East CoastA global clinical diagnostics firm that is dedicated to the continuous development of an expanding menu of assay/instrumentation systems that aid in the detection of antibodies and diseases associated with Autoimmune and Infectious Diseases. The company is seeking a Regulatory Affairs Specialist for its East Coast. Their expertise lies in providing diagnostic solutions for various medical conditions, including hematology, oncology, and metabolic disorders. Their product portfolio includes instruments, reagents, and software designed to assist healthcare professionals in accurately diagnosing and monitoring patient care worldwide.
The Regulatory Affairs Specialist will support the company's US product registrations and regulatory activities, which includes coordinating the accumulation of technical information and preparing submissions for diagnostic device licenses to various governmental regulatory agencies. Key duties include:
Drafting, editing, and compiling technical files and design dossiers in support of EU/UK regulatory filings;Participating in new product development core teams and creating regulatory strategies, representing the RA function group in product design phase reviews, and providing regulatory considerations to the design team;Maintaining country-specific site registration requirements;Preparing submission files for US 510k submission and CR registration;Assisting in preparing documentation for product incident reporting as required;Assisting with the preparation of annual surveillance reports on approved products;Maintaining current regulatory knowledge by attending regulatory seminars and meetings;Maintaining current regulatory databases to produce various reports as needed;Reviewing labeling, package inserts, promotional materials, and company website to meet FDA regulatory requirements;Maintaining Essential Requirements Checklists to ensure that applicable standards are utilized and updated as revisions are introduced;Compiling Technical Documentation for historical files;Assisting OEM customers in obtaining the CE mark on their products.Required Experience:• Minimum 4-6 years industry experience with 2-3 years experience in preparation and submission of 510k and CE technical files.
Required Education:• Bachelor's in a related discipline or equivalency.
Work Experience, Skills and Education Required:Strong working knowledge of medical device regulations and terminologies;Excellent written and oral communication, and technical writing and editing skills;Ability to write clear, understandable technical documentation;Skilled at analyzing and summarizing data;Proficient with Microsoft Office;Ability to manage and prioritize multiple projects;Ability to follow written and verbal direction with a high level of accuracy;Ability to work in a team setting;Knowledge of QSRs & ISO 13485; IVDD/IVDR, MDD/MDR, UK MDR 2002, CMDR, GMP, and 21 CFR.GRN West Palm Beach
9897 Lake Worth Road, Suite 202
Lake Worth, FL 33467 USA
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