Senior Regulatory Affairs Specialist

Stryker is an exceptional company with exceptional people who deliver exceptional results. We have differentiated ourselves by advancing meaningful innovations, creating cost-effective solutions for and improving the lives of our global customers and patients. As a winner of the 2007 and 2008 Gallup Great Workplace Award, we have demonstrated that Stryker has one of the most productive and engaged workforces in the world. Our exceptional results fuel ongoing opportunities for Stryker employees to build outstanding careers and to develop and grow both personally and professionally. Our work environment attracts many different kinds of talented and driven people who love to win and serve others. We always put quality first. We hold ourselves accountable to reach or exceed our goals and continually improve everything we do. These attributes are shared by the employees that make up Stryker. They are the things that bring us together and serve as the foundation of all we do. And they are the enablers of both our past and future success.

Stryker is one of the world’s leading medical technology companies with the most broadly based range of products in orthopaedics and a significant presence in other medical specialties. The Company's products include implants used in joint replacement, trauma, craniomaxillofacial and spinal surgeries; biologics; surgical, neurologic, ear, nose & throat and interventional pain equipment; endoscopic, surgical navigation, communications and digital imaging systems; as well as patient handling and emergency medical equipment. For more information about Stryker, please visit the company web site at: http://www.stryker.com

Develop international and domestic regulatory submission strategies. Lead preparation efforts for FDA 510(k), PMA, and IDE submission documentation. Prepare international regulatory filing and registration documentation. Conduct device research to support regulatory submissions. Review product/process, advertising and promotional material changes to determine regulatory compliance and submission implications. Participate on development and clinical trial teams. Responsibilities include:" Implementation of international and domestic regulatory strategies. " Prepare 510 (k) s PMA s and IDE s submission applications. " Prepare design dossiers for review by notified body. " Research current domestic and international regulatory requirements. " Submit product registrations and applications to foreign governments as required, i.e. TGA., DOH. " Review and approve product changes in accordance with regulatory guidelines. " Review and approve advertising and promotional materials for regulatory implications. " Participate and contribute to project teams." Must have extensive experience and expertise with PMA, 510(k) and IDE submissions. " Previous experience with Class III implantable device submissions required. Powered implantable device experience is preferred." Previous experience with international regulatory submissions desired. " Previous experience using word processing, spreadsheet, data management software programs desired. " Technical writing and fundamental problem solving skills required. " RAPS certification a plus. " Quality assurance experience is not a consideration." Bachelor of Science degree in a related field. Advanced degree preferred." Technical writing and communication skill desired. " Scientific / medical background and education desired ." Computer knowledge and willingness to learn specific software applications is essential. " The candidate should be innovative, people oriented with good project management skills and must be able to work independently." The ideal candidate will have been the lead Regulatory/Clinical member of a design team that successfully commercialized a Class III powered implantable for either cardiac, spinal or neurological applications.Stryker is an equal employment opportunity/affirmative action employer committed to hiring a diverse workforce.To read more about Stryker, please visit our website at www.stryker.com