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Job #03558

About our client Our client is a leading medical device company that is focused on the design, development, and marketing of products for the treatment of spine disorders. The company has an impressive financial track record, an experienced management team and a reputation for innovation. This is a strong opportunity for someone that wants to put their drive and initiative to work! Position Location Regulatory Affairs Associate Southern California Salary Highly competitive package, commensurate with experience Responsibilities General Summary:- Provides regulatory expertise and support for Company products and business objectives by performing the following duties. 1. Responsible for preparation and maintenance of U.S. regulatory PMA submissions and registrations to acquire appropriate commercial distribution clearances and approvals in an expeditious manner 2. Interacts with regulatory agencies and certifying bodies for pre-approval site inspections, presentations, and submissions 3. Assists with preparing for, and attending, meetings with staff of the U.S. regulatory agencies, where necessary 4. Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry 5. Reviews and approves labeling, advertising, and promotional materials for compliance with U.S. and international regulations, and ensure that product claims are consistent with premarket clearances 6. Reviews and approves new documents and product changes for compliance and to determine if a new regulatory submission as required 7. Obtains updated information on changes to applicable regulations and standards to ensure continuing compliance. Present major regulatory issues or changes to applicable regulations and standards to executive staff with recommended actions as required 8. Represents regulatory affairs on various design and development teams by attending team meetings and providing the required plans, procedures and regulatory decisions. Confer with other departments about the regulatory requirements of new product designs and/or changes to existing designs 9. Assists Engineering in maintenance of Design History Files and related records on an as needed basis, and where regulatory responsibilities permit 10. Reviews departmental procedures and recommends streamlining solutions 11. Responsible for attending such conferences, seminars, professional meetings, and other public forums as are relevant to the regulatory interests of Company 12. Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485 Requirements 1. Medical Device and PMA submission experience are essential 2. Bachelor's degree from four-year college or university; 4+ years related experience 3. Must have demonstrated success in management of regulatory submission activities 4. Previous interactions with regulatory authorities leading to positive outcomes 5. Strong technical knowledge of medical products 6. Strong technical writing skills