REGULATORY AFFAIRS SPECIALIST
A major company whose purpose is to transform the practice of medicine through breakthrough science and make a positive impact on our people and the communities we serve.
Join us to make a positive impact in health care!!
Required
- Regulatory Affairs experience with Medical Devices
- Registrations and 510k
- Cross functional teamwork
Interview process will be virtual
The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new / modified product, regulatory operation and processes, post-market surveillance.
- Perform regulatory assessments for product changes including regulatory reportability decisions
- Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions
- Support regulatory filing like a 510(k) or Pre-submission or a new / amended Health Canada License application for a Class II new product and may include renewal of Licenses
- Support international regulatory filing
- Assist in streamlining or updating regulatory processes
- Assist in regulatory intelligence activities
- Assist in post-market surveillance activities, such as complaint handling and vigilance reporting
- Assist in regulatory involved QMS activities, such as CAPA, Non-Conformance
- Perform other related assignments as required
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