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Regulatory Affairs Specialist II/Sr.
Waltham, MA, 02454
Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus on assuring company compliance to US 510k, Health Canada Licensing, International Device Submissions, Licensing and Re...
Principal Regulatory Affairs Specialist
Bedford, MA, 01730
Overview: Werfen Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and...
Principal Regulatory Affairs Specialist
Lawrence, MA, 01840
Position Summary: The incumbent will manage the regulatory process, both domestic and international markets, for NxStage Medical, Inc. products and provide regulatory input into key quality system processes, such as design controls, change control...
Regulatory Affairs Specialist
Cambridge, MA, 02114
Responsibilities: - Your main tasks will be related to the regulatory aspects of the development or improvement of products, including the management and application of Design Controls and the preparation of regulatory submissions and pre-...
Regulatory Affairs Specialist V
Cambridge, MA
- Support the preparation of regulatory documentation and submission activities to meet business and agency milestones. - Lead the development and submission of initial INDs. - Create submission plans and manage timelines in MS Proje...