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 worldÂ’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.
Ensures regulatory compliance by completing the appropriate filings and documentation pertaining to incidents of injury, product approval and product registration and recall as required by the Food and Drug Administration.
·4-5 years regulatory experience in the medical device industry (ideally pre-market analysis).
·Bachelor’s degree (B.S. or B.A.) in related field.
·Previous experience in legal, technical or medically related area preferred.
·Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to lift, carry, etc. Generally involves sitting most of the time.
·Must be able to review printed material.
·Must be able to communicate with others telephonically.
·Must be able to use common office equipment (e.g. PC, telephone, fax machine, etc.).
·Ability to understand and explain detailed regulatory compliance programs and/or issues.
·Ensure that existing approvals and docs are maintained.
·Provide input on and review protocol and reports for design verification and validation.
·Participate in design reviews of products under development.
·Responsible for product release approval.
·Prepare complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), PMA, Shonin, Design Dossier, Technical File, and Certificates to Foreign Government.
·Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
·4-5 years regulatory experience in the medical device industry (ideally pre-market analysis).
·Bachelor’s degree (B.S. or B.A.) in related field.
·Previous experience in legal, technical or medically related area preferred.
·Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently to lift, carry, etc. Generally involves sitting most of the time.
·Must be able to review printed material.
·Must be able to communicate with others telephonically.
·Must be able to use common office equipment (e.g. PC, telephone, fax machine, etc.).
·Ability to understand and explain detailed regulatory compliance programs and/or issues.
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.jobs.
