Remote, Regulatory Affairs, Medical Devices, Consultant
- Employer
- GForce Life Sciences
- Location
- Fort Worth, Texas, US
- Salary
- Competitive
- Closing date
- Jan 15, 2022
View more
- 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
Mandatory Requirements
Term & Start
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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