BACKGROUND:
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 worlds 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.

RESPONSIBILITIES:
Under direct supervision, Associates will learn and develop skills in the following and within time, be able to demonstrate these duties: Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines. Ensure compliance to all US, EU and SO international requirements and corporate policies and procedures regarding submissions and other requirements for market approval of medical devices/combination products. Participate in cross functional team activities from initial stages through securing government approvals. Apply scientific principles to understanding safety and efficacy on a wide range of products.

This position requires the maximum amount of supervision.

• Associate will learn to perform, and thus demonstrate the following duties and responsibilities:
• Participate on product development teams to insure US and other international regulatory requirements are incorporated as part of the development process
• Author submissions and other regulatory documents to obtain approval to bring new or modified products to market
• Assist in post market submissions (progress reports, annual reports etc.)
• Support marketing, R&D and manufacturing teams in regulatory assesment of proposed changes or product transfers
• Address and advise teams on appropriate pathways to market
• Interface and coordinate with the FDA and other regulatory agencies on submissions, approvals or other issues
• Establish and maintain regulatory information systems both electronically and hard copy
• Interpret existing and/or new regulatory requirements as they relate to company products and procedures. Communicate this to appropriate personnell
• Review and approve ECN's, OCN's, etc. while considering both US and international regulatory requirements
• Prepare and update US product listings
• Communicate any FDA correspondence on submissions to the appropriate team(s) and RA management
• Participate in BPX project teams
• Labeling, marketing, product transfer and literature review pre and post market
• Technical file and Design Dossier construction
• Assist the RA Manager and others with the development, implementation and maintenance of regulatory SOP's
• Participate in continuous (breakthrough) improvement activity and process re-engineering projects in support of Stryker Orthopaedics Business Process Excellence initiative.

REQUIREMENTS:

• 0-2 years experience in FDA regulated industry
• 510(k),IDE,PMA (original/revision/supplements) preparation experience or training preferred
• Working knowledge or understanding of Medical Device Regulations (FDA required, international a plus)
• Team based work environment experience preferred and/or ability to work in teams and independently
• Strong interpersonal, written, oral, communication, organizational and planning skills
• Working knowledge of personal computer systems and desktop office applications
• Sound understanding of scientific principles BA/BS in Scientific discipline or equivalent work experience RAC certification desired
• BA/BS in Scientific discipline or equivalent work experience RAC certification desired

HOW TO APPLY:
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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 http://www.stryker.jobs. Additional Information Reference Code: 10275BR. Contact Information: Stryker http://www.stryker.com.