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Job Description & Requirements
MANAGER, REGULATORY AFFAIRS Qualifications: • A minimum of a Bachelor's degree in a Scientific or related Discipline is required, BSMT is a plus. • Minimum of 8-10 years' experience in an FDA regulated Medical Device or Pharmaceuticals Industry Required, IVD and/or Biologics Industry experience preferred. • A minimum of 5 years' experience developing and executing Regulatory Strategies for complex 510(k) and/or BLA development programs is required, In Vitro Diagnostic Medical Device experience is preferred. • A working knowledge of US, EU, and International Regulations, FDA, etc. and guidance for Medical Devices, specifically IVDs is Required. • Experience developing Regulatory Strategies and an understanding of Product Development is required. • Excellent interpersonal, teamwork and verbal/written communication skills are required. • Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously are required. • The ability to demonstrate model behavior, understands priorities and encourages others to drive for results will be needed. • Ability to mentor junior level staff as well as cross-train with peers • The ability to work with business partners across geographies and time zones is critical. • 10-20% travel, domestic.
MANAGER, REGULATORY AFFAIRS: The Opportunity The Manager, Regulatory Affairs will contribute to Transfusion Medicine (TM) Regulatory Strategies and content plans. The primary responsibility is to support the day-to-day Regulatory Affairs operations within the Transfusion Medicine Regulatory Affairs Business Field and will manage and oversee the coordination, compilation and submission of Regulatory Applications to Regulatory Agencies. The Responsibilities • Responsible for interpreting regulatory requirements and determining strategy to obtain registrations. Independently make decisions regarding work processes or operational plans and schedules in order to achieve department and project objectives. • Represent Company to US Regulatory agencies and interact with EU, International Health Ministry personnel to expedite pending applications, resolve Regulatory matters and manage development meetings for Regulatory Submissions. • Provide guidance to business partners regarding Regulatory requirements including indications of risk and approximate timing for approvals for planning purposes. Supports both new product development and currently marketed product portfolio within the Transfusion Medicine Business Field. • Independently execute activities related to maintaining compliant Regulatory status for marketed products including annual reporting, change management, labeling review, etc. • Actively represent Company in External influence activities with Industry Trade associations, Standardization organizations etc. to stay abreast and impact policies and standards applicable to the Company business.
MANAGER, REGULATORY AFFAIRS. Position may possibly extend to one year. This Job replaces Job 2697, as resumes were not responsive. If you submitted a resumes to 2697 and it was Submitted, please re-submit to this job. If not submitted under 2697, please do not submit to this requisition. Thank you.
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