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Remote, Regulatory Affairs, Medical Devices, Consultant

Company: GForce Life Sciences
Location: Seattle
Posted on: January 15, 2022

Job Description:

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

Keywords: GForce Life Sciences, Seattle , Remote, Regulatory Affairs, Medical Devices, Consultant, Professions , Seattle, Washington

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