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Remote, Regulatory Affairs, Medical Devices, Consultant

Employer
GForce Life Sciences
Location
Fort Worth, Texas, US
Salary
Competitive
Closing date
Jan 15, 2022

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Sector
Consultancy/Private Sector
Field
Conservation science
Discipline
Other
Salary Type
Salary
Employment Type
Full time
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Regulatory Affairs, Medical Devices, Consultant

Summary

Our client, a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, has engaged GForce to identify a Senior Regulatory Specialist. This person will be responsible for Regulatory registrations/filings, Regulatory operations support, Quality Management System implementation & coordination in addition to helping provide strategy for future regulatory changes.

Duties / Expectations of Role
  • Plans, organizes, prepares, and maintains regulatory registrations and filings that are supported by distributors
  • Determines the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes
  • Monitors regulatory changes in indirect markets to ensure compliance to local regulations are met and partner with distributors to align
  • Interprets regulatory documents and interfaces either directly with the regulatory body or indirectly through a distributor or consultant for timely approval of products /product changes
  • Communicates registration strategy with sales & marketing stakeholders
  • Implements and supports Quality Management System activities such as CAPA, documentation, training, management review, internal & external audits, Field Safety Corrective Actions
  • Ensures that company procedures, processes and documentation meet the required guidelines for maintaining compliance to the Quality Management System, ISO 13485, and other applicable regulations
  • Supports the Regulatory Affairs function by ensuring compliance of activities with current internal and external requirements


Mandatory Requirements
  • A Bachelor's or Master's degree in medical technology, life sciences or similar
  • 5+ years of significant experience in similar function
  • Knowledge of emerging market regulations & regulatory strategy/intelligence
  • Strong knowledge of Quality Management System requirements to ISO 13485 required and broad understanding of what it takes to work in a regulated environment
  • Ability to be effective in complex projects with ambiguity and/or rapid change
  • Computer literacy (PC, Microsoft, Outlook), experience with Agile, CRM and SAP a plus


Term & Start
  • 6+month contract to permanent/direct hire (client has permanent budget set aside)
  • 40hrs/week - full time
  • Benefits available (health, dental, vision, 401k)
  • Start ASAP
  • 100% remote/home-based
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