SUMMARY: The position of Regulatory Affairs Specialist III is responsible for the development, retrieval and maintenance of regulatory submissions, documentation, annual reporting for class I, II and III medical devices and Quality Systems compliance throughout the organization. This position will work closely with other concerned personnel to prepare submissions for new products and product changes, and annual reports, as required, to ensure continued compliance, timely approval for clinical studies and market release. ESSENTIAL DUTIES: * Responsible for all worldwide regulatory submissions for companys Preventive Division, including FDA pre market approval, 510K, annual reports, and all amendments, etc. for all regulatory bodies. * Reviews significant compliance issues with manager as necessary, and negotiates submission issues directly with comapny Corporate, divisional personnel and/or agency personnel. * Prepares or assists in the preparation of regulatory strategies/plans and worldwide requirements with partner organizations. * Provides data in support of business and product information/submissions to inter-company and international partners to enable development of strategies and requirements, and communicates that information to business teams. * Provides updates to SBU on new and changing regulations and determines their effect on our products and business, providing guidance on changes required. * Provides regulatory support to currently marketed products as necessary. Supports the ongoing compliance of the SBU by identifying and correcting gaps in procedures as required and designing and presenting training programs to educate associates at all levels within the Division. * Develops and provides training for all staff relative to the quality system and general regulatory requirements impacting the organization. * Supports New Product Development teams, based on market needs, to input into the development process, document and implement regulatory strategies, including registration requirements, needed to help facilitate timely launch of new products. * Review and approval of labeling through Label Review Committee, including UDI requirements. * May manage personnel within group with responsibilities to include coaching, training, and application of policies, programs, and procedures. Assures that a positive employee relations environment is maintained through effective communication. * Authors/reviews technical reports as required. RELATED DUTIES: * Effectively utilize resources that are not directly under her/his control to achieve both individual and team goals. * Interacts with all levels of the Division, Corporate Compliance, Interco Divisions, Dealers, and Customers. * Prepares and submits periodic reports, as required. * Performs special tasks and assignments, as required. MINIMUM QUALIFICATIONS: Training and Experience * Bachelors Degree (BS or BA) in technical discipline, preferably in a life sciences field. * Minimum of 5 years experience in regulatory affairs for a pharmaceutical, biotech, or medical device company. Experience with Class III medical device manufacturing is preferred. * Project management experience. * Previous domestic/international submissions experience. * Regulatory Affairs Certification (RAC) is desirable. * Successful candidate must have the ability to communicate and work cross-functionally at all levels. Knowledge, Abilities, and Skills * Thorough understanding of FDA Quality System regulation, ISO 13485, ISO 14971, MDD (93/42/EEC). Knowledge of other international regulations including Canada, Australia, Brazil and Japan is desirable. * Strong oral and written communication skills are required and ability to work with all levels of an organization. * Ability to manage multiple complex tasks and to set priorities. * Excellent attention-to-detail and appreciation of deadlines. * Working knowledge of Microsoft Office programs, including PowerPoint, Excel, Access, and Word. * Experience using TrackWise and SmartSolve (or other electronic data and record management programs) preferred * A wide degree of creativity and latitude is expected. * Strong leadership ability. * Good presentation skills and the ability to provide training on topics related to duties and responsibilities as outlined. * Ability to solve practical problems * Conduct business in a manner which reflects well on Dentsply Sirona Preventive. * Dependability. * Ability to work independently About Scientific Search: Since 1983, Scientific Search has been placing technical, management, and executive level professionals. We have been named one of the fastest growing, privately held companies in South Jersey by the Philadelphia Business Journal six times, and one of the prestigious Philadelphia 100 companies on four occasions including this past year. We are also a member of the nationally recognized Inc. 5000. In 2015, we were recognized as one of the best places to work in NJ.
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Website : http://www.scientificsearch.com/
Scientific Search is a leader in the placement of technology professionals. Our areas of specialization include information technology, pharmaceutical & biotech, engineering, and market research. Our client base is predominately centered in the corridor stretching from Philadelphia to New Jersey and the New York metropolitan area. We do, however, conduct a significant portion of our business outside of our primary market territory, both regionally and nationally. We are a full service employment agency offering multiple staffing options. From contract placements to direct placements and everything in between, Scientific Search works with employers and technology professionals to find the perfect solution. Scientific Search was founded in 1983 and has been providing recruiting and staffing excellence for twenty years. We have survived and excelled through a combination of hard work, knowledge and integrity. We are the firm that leading employers depend on to solve their staffing needs, and technology professionals trust to find challenging, rewarding positions.