Senior Associate, Regulatory Affairs

Provides regulatory support and expertise associated with global and US registration of device electro mechanical products, including in-depth analysis of the requirements and tracking of deliverables. With oversight, supports creation of global regulatory strategies and assists in execution including creation and maintenance of global registration dossiers. Assures full regulatory compliance of alldocumentationfor submissions and change management.

• Provides regulatory advice and support to assigned products/teams.
  
  Identifies and communicates registration needs and strategies.
  
  Maintains awareness of applicable regulations.
• Plans and organizes registration packages for device products.
  
  Prepares registration packages inline with local regulatory requirements and guidelines.
• With oversight,servesasaliaisonwithregulatoryagenciespertainingtoassignedproducts.
  
  Assistsinthepreparationofagencymeetingpackagesandstrategiesforagencymeetings.
• Evaluates manufacturing and labeling changes for regulatory impact.
  
  Accurately describesthesechanges for ease of regulatory agency review.
• Work with region and country RA counterparts to evaluate changes for regulatory impact andto ensure compliance with applicable regulations.
  
  Accurately describes these changes for easeofregulatory agency review.
• Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assignedproductor project team.

• Review and approve critical documents, seeking guidance when necessary.
  
  Review technicalreportsanddetermineacceptabilityforregulatory submission.
• Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
• Interpret global regulations and assure regulatory compliance, minimizing development costsand cycles.
• Defineandnegotiateregulatorystrategywithsupervision.
• Exercisegoodjudgmentwithinpolicyandregulations.
• Responsible for tracking and completion of assigned registration activities.
• Accountable for accuracy of work and meeting multiple, simultaneous deadlines.
  
  Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can resultinmissed sales or regulatory action letter.
• Follows scientific arguments, identifies regulatory scientific data needs and solves regulatoryissueswith alignment ofregulatorymanagement.
• Presentsscientificdataeffectivelyorallyandinwritinginalogical andpersuasivemanner.
• Providesdailyregulatorysupporttonewproductdevelopmentteamsandcommercialsupportwithguidance.
• Participates in preparing regulatory strategies.
  
  Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution.
• Actsindependentlyonallroutineissues,makesjudgmentandexecutes.

• Must be at least 18 years of age
• High School Diploma required
• Bachelor’s degree from an accredited collegein pharmacy, biology, chemistry, pharmacology, engineering orrelatedsubjector university is required
• Master’sDegreeorP.H.Dpreferred
• RACCertificationpreferred
• Seven plus years of experience in Medical Products Industry with a minimum of 3 years ofexperiencein Regulatory Affairs.
• Abletoleadscientificargumentsandapplyanalyticalandlogicalreasonings.
• Abilitytoeffectivelyprioritizeworkloadandmultitaskwithminimalsupervision.
• Goodinterpersonalskills.
• Goodoralandwrittencommunicationsskills.
• Demonstratedprojectmanagementskills.
• Demonstratedcriticalthinking,contingencyplanningandnegotiatingskills.
• Understanding of regulatory and business needs with ability to establish direction andinfluencecross functional team members.

• This is largely a…