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Regulatory Affairs Specialist

Employer
Project Consulting Group
Location
Minnesota
Salary
Competitive

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This positions leads the preparation and submission for regulatory approvals and acts independently to identify and resolve problems . Provides regulatory guidance to cross-functional partners and demonstrates strategic thinking and creativity in support of programs. Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices. May require an advanced degree and 5-8 years of direct experience in the field. Recent experience with Class III implantable medical devices; Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements; knowledge of FDA PMA guidance documents and CFR regulations. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. May lead and direct the work of others. A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department. Job Duties: List the significant/essential duties, tasks or responsibilities which employees in this position are required to perform. Prepares robust regulatory applications to achieve departmental and organizational objectives. Creates, reviews and approves engineering change orders. Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise. Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail. Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel. Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations. Interfaces directly with FDA and other regulatory agencies. Supports the product release process by creating GTS licenses or reviewing and approving requests for product release. Conducts reviews of product and manufacturing changes for compliance with applicable regulations. Reviews protocols and reports to support regulatory submissions. Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements. Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Provides mentoring and leadership to Regulatory Specialist I and II team members Performs other related duties and responsibilities, on occasion, as assigned - provided by Dice

regulatory affairs, medical device, pma, compliance, fda

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