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Responsible for the preparation and documentation of regulatory submissions to government agencies. Works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors. Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Normally receives no instructions on routine work, general instructions on new assignments. May provide leadership by assigning work and resolving complex problems. DUTIES AND RESPONSIBILITIES 1. With direction, develops plans for regulatory strategies. Participates in project team meetings and provides regulatory advice. Seeks solutions and alternatives to problems and issues. 2. Prepares regulatory documents for regional submissions. Acquires information from appropriate technical groups and project personnel which addresses performance of diagnostic reagents, instruments, and software. Assures adequate documentation exists for product claims and directs timely review of regulatory documents. 3. Acts as a liaison for international divisions by tracking requests for information and monitoring international laws. Provides product performance data as requested by international personnel and other corporate groups. 4. Monitors FDA and other agency laws and regulations, and provides recommendations and assistance to ensure company compliance. 5. Direct certification application activities including sending and tracking certification letters. Maintain tracking log, and supply global registration requests. 6. Provides metrics for regulatory management reporting and helps to identify areas for further monitoring for global product development system (GPDS) improvements. 7. Track global registration status for project teams and new products. Log, track, and prepare report from eGPS system. 8. Brings Regulatory Affairs questions/issues to the attention of RA management. 9. Preparing responses to agency’s questions with good writing and communication skills. 10. Performs other related duties and assignments as required.
MINIMUM QUALIFICATIONS • A minimum of a Bachelor's of Science degree • A minimum of 2 years’ experience working in a medical device environment. • A minimum of 2 years prior experience working on product regulatory submissions. KNOWLEDGE AND SKILLS • The ideal candidate would have a degree in a scientific discipline such as biology, microbiology, chemistry, engineering, or medical technology. • Individuals who have obtained a Regulatory Certification are a plus. • Previous experience working for a medical device manufacturer. • Knowledge of regulations related to product lasers. • Experience with flow cytometry, hematology, and/or immunoassay are a plus. • Orientation for detail work product, with emphasis on accuracy and completeness. • Effective written and oral communication skills. • Good organizational and planning skills; drives for results. • Effective analytical/problem solving skills. • Good interpersonal skills that involves working well in a team environment and the ability to lead others. • Ability to exercise reasonably independent judgment and discretion within a defined range of policies and practices. • Ability to handle multiple tasks and to prioritize/ schedule work to meet business needs with routine supervision. • Working knowledge of project management and design control. • Ability to identify areas of concern in moderately complex projects and manage change. • Computer literacy (PC, Microsoft Word/Excel/PowerPoint) EDUCATION AND EXPERIENCE Typically requires a BA/BS degree in Chemistry, Biology, Engineering, or Medical Technology and three years of related experience, or equivalent combination of related education and experience.
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