Regulatory Affairs Specialist

Seeking an experienced Regulatory Affairs Specialist for a large medical device company. This will be a W2 position through December 2027.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 devicesWork 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 Company’s 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 productsMaintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminologyPlan, lead and support for internal and Regulatory agency auditsLead and direct engagement with regulatory authorities as requiredInitiate 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 complianceDevelops 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 requirementsOther activities as assigned.