Regulatory Affairs Specialist

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Responsibilities: This position works closely with direct supervision to learn and develop the regulatory skills required to bring medical devices to market and ensure ongoing compliance This position is part of the Regulatory Affairs Compliance team, responsible to ensure local regulatory procedures adhere to government regulations, industry standards, and corporate policies; support internal and external audits; monitor regulatory systems for completeness and accuracy; and support other regulatory compliance activities, as needed Collaborates with Regulatory Affairs, Quality Assurance, and other associates on compliance support activities Understands fundamental global regulatory and quality system requirements Stays informed of new regulations and changes to existing regulations and communicates to management Monitors and analyzes regulatory information systems data; and coordinates actions to address issues Verifies product regulatory information to be submitted to global external databases Provides subject matter expertise on regulatory information systems to Regulatory Affairs team Provides regulatory support for internal and external quality system audits Supports development and implementation of corrective action plans for regulatory compliance findings Maintains FDA device listings and establishment registrations Writes and updates standard operating procedures (SOP), work instructions (WI), and policies and conducts internal training, as needed Conducts gap assessments of new and revised corporate procedures and external regulations and standards, and updates local documents accordingly Coordinates and responds to requests for product data and information Supports regulatory business processes Provides regulatory support for implementation of new systems and processes Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. Requirements: Bachelor's degree or higher, preferably in a scientific discipline. t Client, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. FDA Medical Device Regulations, Medical Device Regulations, Regulatory Compliance. Global Regulatory, Regulatory Affairs Compliance, Regulatory Processes, Standard Operating Procedure (SOP).
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Location:
Salt Lake City, UT, United States
Category:
Business And Financial Operations Occupations

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