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Job #03008

About our client Our client is a life science company focused on the development of products that eliminate contagious pathogens. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term development of it's employees. Position Location Regulatory Affairs Manager Malvern, Pennsylvania Salary Highly competitive package, commensurate with experience Responsibilities 1) Develop and implement global regulatory strategy aligned with business strategy 2) Monitor external regulatory developments, identify risks and communicate potential courses of action to management. 3) Prepare and submit regulatory approval documents 4) Develop and maintain strong professional relationships with regulatory agencies to facilitate submission process and to efficiently manage periodic inquiries 5) Provide inputs regarding conduct of clinical trials and data collection 6) Review product and process change proposals for impact on existing regulatory approvals, clearances and notification requirements 7) Ensure compliance with regulatory and company design control requirements 8) Serve as the technical expert in maintaining and building a regulatory library of products for all domestic and international regulatory requirements (FDA, CE, OSHA, ISO, EMC, FCC, etc.) 9) Partner with Quality Assurance, Engineering, Microbiology, R&D, Marketing, Sales and other departments to ensure that the company is fully compliant with its regulatory requirements 10) Support Quality Assurance in complaint handling, medical device reporting, vigilance reporting, field actions and label approval 11) Educate and train company employees on regulatory matters to ensure compliance requirements 12) Develop and maintain Material Safety Data Sheets (MSDS) 13) Oversee global submissions, compliance and interpretation 14) Support diverse existing and planned business initiatives 15) Create and implement regulatory strategy Requirements 1) BA/BS in a technical or scientific discipline (advanced degree preferred) 2) 10+ years in QA with minimum 5 years of experience in regulatory affairs 3) Minimum 5 years of experience in medical devices 4) Experience in validations, engineering documentation, Pre-Market Notification 510ks and Pre-Market Approval (PMA) 5) FDA regulatory approval knowledge and experience in interpreting regulatory guidelines 6) Excellent organizational and communication skills 7) Ability to identify compliance risks, make decisions independently and provide recommendations to management in resolving issues (as necessary) 8) Keen attention to detail