REGULATORY AFFAIRS ASSOCIATE Pioneer Surgical Technology
THIS JOB HAS EXPIRED POSTION: This position provides training towards full competency in Regulatory Affairs (RA). Candidates may enter with no prior experience in RA, or may have up to two years + prior RA experience with IDE/PMA exposure. The selected candidate will develop expertise in areas that may include preparation of dossiers for product registrations outside the U.S.; preparation of submissions to the U.S. FDA; U.S. FDA regulations, including labeling regulations; regulations of countries outside the U.S.
SUPERVISION RECEIVED AND EXERCISED: Director of Regulatory and Clinical Affairs
Coordinates and manages FDA regulatory submission process, including authoring and publishing electronic submissions. Reviews planned regulatory submissions and other critical documents to assure they are complete, accurate and consistent with organizational objectives.
Assists in tracking, preparation, printing and/or publishing and mailing submissions to the FDA. Files annual notification, annual establishment, state, federal registrations, product changes to FDA, Health Canada, EU, notified bodies, and other regulatory agencies throughout the world.
Coordinates and manages the development of dossiers for registration of products in countries outside the U.S, including authoring and publishing electronic submissions. Must be skilled in formatting, and revising documents or similar for regulatory submission. Assists in development/maintenance of regulatory/clinical files, records and reporting systems for systematic retrieval of information.
Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products. Provides Regulatory perspective and requirements in cross-functional project teams.
Communicates with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management. Documents, consolidates and maintains oral and written communication with FDA, notified bodies, and clinical investigators.
Ensures documents are prepared in accordance with FDA guidelines and internal guidelines and SOPs. Supports Design Control process. Participates in and conducts Internal Audits.
Maintains external references and lists of national and international regulations, standards and FDA guidance documents that affect the products and operations.
Reviews proposed labeling for compliance with applicable U.S. and international regulations.
Reviews and evaluates promotion and advertising material for compliance with applicable regulations.
Reviews proposed product changes for impact on regulatory status of the product. Monitors changes in the Regulatory environment and provides management with the impact of these changes.
Assists in review and maintenance of relevant guidelines and SOPs.
Reviews change control documents and ascertains Regulatory impact for external and internal documents.
Coordinates the notarization and legalization of regulatory documents.
-This is not an exhaustive list of duties or functions and may not necessarily comprise all of the essential functions-
Bachelor?s degree in Biology, Business, Marketing
Minimum 1 year experience in Regulatory activities for new and existing products or equivalent. International experience a plus.
Strong technical background including expert proficiency in most of the following: Microsoft Word, document publishing, desktop publishing, scanning, Acrobat, Windows, and document management system.
PERCENT TRAVEL REQUIRED
||375 River Park Circle |
Marquette, MI 49855
THIS JOB HAS EXPIRED