Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		Job #07265 About our client Our client is a large diagnostics company headquartered in Maine. They have a variety of products on the market producing well over $1 billion in revenue, and have a strong corporate culture that promotes the professional growth of all employees. This is a great opportunity for the right individual. Position Location Clinical Affairs Specialist ME Salary Highly competitive package, commensurate with experience Responsibilities Partial Job Description 1) Participate in the independent evaluation of study proposals for consistency with company objectives, regulatory compliance requirements and adequacy of study design 2) Develop and write protocols for company supported studies with input from technical, quality assurance and marketing personnel and, as appropriate, regulatory agencies 3) Initiate and monitor assigned clinical/research studies in compliance with all applicable regulations and company procedures 4) Analyze and evaluate clinical data presented in literature or generated as part of company sponsored studies 5) Establish and maintain professional relationships with clinical investigators and regulatory contacts (agency and distributor) as necessary to support clinical studies and regulatory submissions 6) Compose documents for regulatory communications including submissions (pre-IDE, 510(k), PMA, CLIA Waiver, registration dossiers) 7) Monitor status of communications with regulatory agencies and clinical study sites 8) Maintain and manage clinical study and product registration activities in database systems, consistent with company timelines and objectives 9) Construct in-house regulatory files 10) Develop regulatory knowledge of worldwide IVD requirements and coordinate assigned product registration activities 11) Support all clinical affairs activities as needed Requirements Qualifications / Skills Required 1) BA/BS in Chemistry, Biology or other Science 2) 5-7 years of experience in clinical study coordination and/or in biotechnology or related industry 3) Experience in regulatory submissions (510(k), Technical File, PME, IDE), interpretation of FDA or international regulations, and/or clinical study coordination desirable
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