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TITLE: Regulatory Specialist SUMMARY: This position will be responsible for participating in the review of performance data, writing pre-submission communications to FDA, preparation of protocols, and e-Submissions for 510(k) and PMA products. Additionally, this position will be responsible for managing registrations for Latin America and Canada. This position reports to the Director, Regulatory Affairs and interfaces with the Product Managers and Clinical Affairs. ESSENTIAL DUTIES AND RESPONSIBILITIES: Primary responsibilities for Regulatory Specialist with focus on FDA submissions 1. Participate in preparation of pre-submission correspondence with the FDA to determine that all protocols and data collection meet the agency s needs. 2. Participate in the review of all performance data provided by R&D as necessary to determine completeness and accuracy prior to submission. 3. Prepare e-Submissions or PMA submissions with completed documentation and all appropriate forms for new products. a. Prepare documents for CLIA categorization as required. 4. As necessary, prepare Letters to the File for corrections, new instrument launches, etc. 5. Conduct regulatory assessments, labeling and label reviews, when required. 6. Participate in design transfer and change control when required. Primary responsibilities for Regulatory Specialist with focus on International registrations: 1. Prepare and manage all regulatory documents for International (Latin America and Canada) registrations and tenders on a timely basis a. Maintain current registration documentation and ensure that all are up-to-date. b. Interface with Product Management to determine new product availability from TBJ c. Maintain the proper logs, contacts, and processes for authentication for registration documents 2. Conduct regulatory assessments, labeling and label reviews, when required. 3. Participate in design transfer and change control when required. 4. Collaborate and coordinate with marketing to determine future submission requirements. Secondary responsibilities for Regulatory Specialist: Each specialist will be cross-trained to perform the functions of FDA submissions and International registrations in order that the needs of the company continue to be met. QUALIFICATIONS: 1. Understanding of basic immunochemistry and HPLC chemistry. 2. Experience in preparation of submission documents including eSub preparation of 510(k) is desired 3. Regulatory Affairs Certification (RAC) a plus. 4. Experience in clinical trial processes is desirable. 5. Sound knowledge of statistics and regulatory standards that apply to submissions 6. B.S. degree in biology, chemistry, health sciences or engineering. 7. Familiarity with Microsoft Word, Excel, EP Evaluator and Analyze It. 8. Good communication skills, oral and written, and understanding of business related aspects with regards to confidentiality of corporate affairs. 9. Ability to travel as the job requires. 10. Knowledge of Latin American registration requirements a plus 11. Ability to speak Spanish and Portuguese languages a plus 12. 2 years experience in regulatory affairs WORKING CONDITIONS: This position requires visits to customer sites which are medical facilities. These facilities may have certain requirements which Company representatives must meet to gain access, including the requirement for drug, background, and health screening. Employment is contingent on your compliance with the requirements established by each facility, as evidenced by the results of the required screenings. Must agree to provide required immunization records and/or agree to acquire required immunizations in order to gain access to customer sites as required by customers. You may be required to register at vendor credentialing companies.
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Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.
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