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For your reference, we have included the original job posting below.
Regulatory Affairs Specialist
Job Number:
42985466
Company Name:
Stryker Corporation
Job Location:
Flower Mound, TX US
Job Categories:
Healthcare & Medical Science & Biotech
Regulatory Affairs Specialist
Assure the implementation of Regulatory Affairs and Quality Assurance systems and procedures relating to domestic and/or international regulatory requirements. Manage Corrective Action and preventive Action (CAPA) relevant to Regulatory Affairs. Keep appraised of Worldwide Regulatory requirements. Track and report quality/regulatory information to management /associates. Maintain regulatory files and documentation in accordance with records maintenance policies. Conduct training in areas of responsibility. Participate in Regulatory Agency audits.
Qualifications/Work Experience
Five (5) years of experience as a Regulatory Affairs Specialist, Biomedical Engineer, Engineer or equivalent.
Five (5) years experience* with: •Development of regulatory strategies and regulatory submissions for medical devices; •Product development process from early design to device development including user needs assessment, specification development, risk analysis and CAPA analysis; •Development of Quality Management Processes in accordance with 21 CFR Part 820 Quality System Regulation (QSR). •Research and development, product development, as well as Regulatory affairs; and •Pre-IDE submissions with FDA. *Experience concurrent with the above-referred- to industry experience.
Education and/or Special Training
Bachelor of Science in Biomedical Engineering or an equivalent field.
