Sr Regulatory Affairs Specialist

Sr Regulatory Affairs Specialist
Location : 100% REMOTE
Duration : 18+ month
Pay Range : $38/hr - $40/hr

Job Description:
Preparation and review of global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in the preparation of international regulatory submissions for new and modified devices
Work as the RA lead on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Companys product launch timelines in all identified markets.
Manage/lead regulatory-driven project, as directed by management.
Develop and execute global regulatory strategies and support product release for market expansion activities for new and modified products
Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology
Plan, lead and support for internal and Regulatory agency audits
Lead and direct engagement with regulatory authorities as required
Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact to domestic and international product registrations, updating registrations as required to maintain regulatory submission compliance
Develops and maintains company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
Review product labeling to ensure compliance with regulatory requirements