RegIQ Solutions is dedicated to changing the way Medical Devices are brought through the regulatory process by introducing MAGELLAN, the industry’s first Device Compliance Platform. We are seeking a technically savvy Regulatory Affairs Specialist to assist with platform development, commercial launch and growth activities
Maintain and update global regulatory intelligence database.
Building out technical strategy to develop and manage intelligence database
Develop and maintain detailed technical/software process documents
Build out source data for intelligence database via Magellan
Liaise with clients on platform issues, with particular emphasis on intelligence queries and search results
Maintain current level of knowledge on global regulatory requirements
Ensure platform attributes and function are consistent with current regulatory practice
Work with in country representatives as required
Provide client training as required
Maintain effective relationships with Customer Service, Marketing and Operations departments
- A Bachelor’s degree in a scientific or technical discipline is required. RAC designation is an asset.
- 2 to 5 years Regulatory Affairs experience with Medical Devices is required
- Working knowledge of FDA, EU and other international regulations is preferred
- Proficiency with Microsoft Office Products such as Word, Excel and Power Point or equivalent software applications is required
- Working knowledge of technology methods, logic and operational capabilities. Such as Adobe, SQL and websites
- Must demonstrate strong analytical skills as well as the ability to work within an entrepreneurial environment
- Proficiency in other languages is considered an asset
Telecommuting is allowed.
Internal Number: RIQ24718
About RegIQ Solutions
RegIQ Solutions offers a device compliance platform for medical device companies, featuring pre-submission compliance information in over 100 countries as well as post-submission device license management, all managed through the on-board project manager.