Remote, Regulatory Affairs, Medical Devices, Consultant

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