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Senior Regulatory Affairs Manager (Remote Work Flexible)
Ref No.: 18-03589
Location: Rochester, New York
Position Type:Contract
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:Dental Insurance, Medical Insurance
*1 year contract position with additional opportunity based upon performance and continued business need*

The company: Our client is an in vitro diagnostics company that makes products and diagnostic equipment for blood testing. ​

Position Overview:
 
The Senior Regulatory Specialist/Manager, Regulatory Affairs will contribute to Clinical Laboratories (CL) regulatory strategies and content plans.  The primary responsibility is to develop innovative Regulatory strategies in support of new product development programs as well as support the day-to-day regulatory affairs operations within the CL Regulatory Affairs Business Field and will manage and oversee the coordination, compilation and submission of regulatory applications to regulatory agencies.
  
Primary 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 us to US regulatory agencies and interact with 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 CL Business Field.
  • Independently execute activities related to maintaining compliant regulatory status for marketed products including annual reporting, change management, labeling review, etc.
  • Maintain collaborative relationships with Regulators, Trade and Standards Organizations, External business partners, i.e. 3rd party suppliers, Product developers, contractor manufacturers.
  • Maintain good working relationships with Product Development, Product Support, Operations, Marketing and Quality Partners.
  • Ability to lead process improvement projects which may involve cross functional participation in order to improve and develop more efficient approaches for the RA team to achieve its goals.  
  • Thinks “Out of the Box” to optimize RA goals and business value
  • Builds strategic partnerships to further RA and organizational objectives and collaborates with all levels in the refinement of strategic direction for short and long-term business planning.
  • Leverages best practices through industry and internal benchmarking.
 
Educational Requirements:
  • A minimum of Bachelor’s degree in a Scientific or related Discipline is required, BSMT is a plus.
  • RAPS certification desirable.
  
Experience Requirements:
  • Minimum of 8-10 years’ experience in an FDA regulated Medical Device Industry required, IVD and/or biologics Industry experience preferred.
  • A minimum of 5 years’ Experience developing and executing Regulatory strategies for complex 510(k) development programs is required, IVD Medical Device experience is preferred.
  • A working knowledge of US, EU, and International Regulations, FDA, and guidance for Medical Devices is required, specifically for IVDs preferred.
  • 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 lead process improvement projects which may involve cross functional participation in order to improve and develop more efficient approaches for the RA team to achieve its goals.
  • Ability to provide Regulatory leadership in a matrixed organization.    
  • The ability to work with business partners across geographies and time zones is critical.
  • Ability to effectively negotiate and influence upper management, other departments and regulatory agencies is required. 
  • Experience working with cross-functional teams is required in addition to previous aptitude thriving within a complex regulatory environment.  
  • Critical thinking and decision-making skills along with the ability to provide innovative solutions/strategies within the boundaries of FDA regulation.
Pay Rate: $95 to $105 per hour bassed upon qualifications
Drug and background screenings required


On-Board Services provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.