Regulatory Affairs Specialist

Stryker is an exceptional company with exceptional people who deliver exceptional results. We have differentiated ourselves by responding in innovative ways to the needs of our global customers and patients. We have created a work environment that attracts talented, driven people who love to win and to serve others. We hold ourselves accountable to reach or exceed our goals and to continually improve everything we do. These attributes are shared by the employees that make up Stryker. They are the things that bring us together. They are 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. Stryker works with respected medical professionals to help people lead more active and more satisfying lives. 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. The Company's website address is http://www.stryker.com

JOB DESCRIPTION:
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 govenrment approvals. Apply scientific principles to understanding safety and efficacy on a wide range of products.ESSENTIAL 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.510(k),IDE,PMA (original/revision/supplements) preparationMinimum 1 year experience in FDA regulated industryWorking knowledge of Medical Device Regulations (FDA required, international a plus)Direct interaction with FDA reviewers/inspectorsTeam based work environment experience preferredStrong interpersonal, written, oral, communication, organizational and planning skillsWorking knowledge of personal computer systems and desktop office applicationsSound understanding of scientific principlesBA/BS in Scientific discipline or equivalent work experienceRAC certification desired.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