Plan, organize and implement strategies and activities required to procure regulatory approval for new and revised product lines. Ensure compliance with all US, EU and SO international requirements and corporate policies and procedures regarding submissions for market approval of medical devices/combination products. This position requires minimal to no supervision.
• 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. • Mentor to other members of the Clinical Research team.
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Qualifications/Work Experience
• 510(k),IDE,PMA (original/revision/supplements) preparation, submission and clearance/approval • Minimum 3 years experience in FDA regulated industry • Working knowledge of Medical Device Regulations (FDA required, international a plus) • Direct interaction with FDA reviewers/inspectors • Team based work environment experience preferred with leadership of teams 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 • Seniors will need to have demonstrated sustained exceptional performance and /or have more experience in a large roll.
Education and/or Special Training
BA/BS in Scientific discipline or equivalent work experience. RAC certification desired.
