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For your reference, we have included the original job posting below.
Regulatory Affairs Specialist
Job Number:
42308107
Company Name:
Stryker Corporation
Job Location:
Allendale, NJ US
Job Categories:
Healthcare & Medical Science & Biotech
Regulatory Affairs Specialist
• Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines under the guidance of more senior regulatory professionals. • Ensure compliance to all US, EU and Spine 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
• Participate on product development teams to insure US and EU 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 under the supervision of more experienced regulatory professionals • Interface and coordinate with the FDA, Notified Bodies, Competent Authorities and other regulatory agencies on submissions, approvals or other issues under the supervision of more experienced regulatory professionals • 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 personnel • Review and approve product and manufacturing changes while considering both US and EU regulatory requirements • Prepare and update US product listings and EU registrations • Communicate any FDA correspondence on submissions to the appropriate team(s) and RA management • Conduct labeling, marketing, product transfer and literature review pre and post market under the supervision of a more experienced regulatory professional • Prepare Technical files and Design Dossiers to support CE Marking under the supervision of a more experienced regulatory professional • Assist the RA Managers and others with the development, implementation and maintenance of regulatory SOP's • Participate in other regulatory projects as assigned
Qualifications/Work Experience
• 510(k) and CE Marking; IDE,PMA (original/revision/supplements) preparation a plus • Minimum 1 year experience in FDA regulated industry • Working knowledge of Medical Device Regulations (FDA and EU required) • Direct interaction with FDA reviewers/inspectors • Team based work environment experience preferred • Strong interpersonal, written, oral, communication, organizational and planning skills • Working knowledge of personal computer systems and desktop office applications Sound understanding of scientific principles
Education and/or Special Training
4 year degree in scientific area preferred; RAC certification desirable
