Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.  Job #02572 About our client Our client is a rapidly growing medical device company headquartered in San Diego that is known for innovative strides in the development and commercialization of minimally invasive therapies. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Regulatory Affairs Associate San Diego, CA Salary Highly competitive package, commensurate with experience Responsibilities 1) Prepare and maintain both U.S. and foreign regulatory submissions as well as other pre-market filings and registrations 2) Acquire appropriate commercial distribution clearances and approvals in an expeditious manner 3) Assist in providing regulatory training for shareowners, consultants and suppliers (when necessary) 4) Interact with regulatory agencies and certifying bodies for site inspections, presentations and submissions 5) Review and approve labeling, advertising and promotional materials for compliance with U.S. and international regulations 6) Ensure that product claims are consistent with the pre-market clearances 7) Prepare and maintain technical files and Declarations of Conformity for products as required by European Medical Device Directive 93/42/EEC, and in supporting maintenance of CE Mark for those products 8) Review technical publications, articles and abstracts to stay abreast of regulatory and technical developments in the industry 9) Assist with preparing for and attending meetings with staff of the U.S. and foreign regulatory agencies (where necessary) 10) Review and approve new documents and product changes for compliance as well as determine if a new regulatory submission is required 11) Maintain federal facility registration, state licenses and device and tissue listings 12) Obtain updated information on changes to applicable regulations and standards to ensure continuing compliance 13) Present major regulatory issues or changes to applicable regulations and standards to executive staff with recommended actions (as required) 14) Represent regulatory affairs on various design and development teams by attending team meetings and providing the required plans, procedures and regulatory decisions 15) Communicate with other departments about the regulatory requirements of new product designs and/or changes to existing designs 16) Assist the Engineering Department in the maintenance of design history files and related records on an as-needed basis, and where regulatory responsibilities permit 17) Review departmental procedures and recommend streamlining solutions 18) Assist Quality Assurance in the conduct of internal and external audits on an as-needed basis and where regulatory responsibilities permit 19) Attend conferences, seminars, professional meetings and other public forums as are relevant to the regulatory interests of the company 20) Perform duties in compliance with applicable FDA and state regulations as well as standards, including, but not limited to ISO 13485
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