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For your reference, we have included the original job posting below.
Regulatory Affairs Analyst
Job Number:
42019346
Company Name:
Stryker Corporation
Job Location:
San Jose, CA US
Job Categories:
Healthcare & Medical Science & Biotech
Regulatory Affairs Analyst
GENERAL DESCRIPTION: Ensures regulatory compliance by completing the appropriate filings and documentation pertaining to incidents of injury, product approval and product registration and recall as required by the Food and Drug Administration.
ESSENTIAL FUNCTIONS: • Ensure that existing approvals and docs are maintained. • Provide input on and review protocol and reports for design verification and validation. • Participate in design reviews of products under development. • Responsible for product release approval. • Prepare complex submissions to gain global approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), PMA, Shonin, Design Dossier, Technical File, and Certificates to Foreign Government. • Develop and maintain positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies, potential regulatory pathways, compliance test requirements, clarification, and follow-up of submissions under review.
J2W:Campaign2012
Qualifications/Work Experience
•3 -6 years regulatory experience in the medical device industry. •Must be able to analyze and resolve non-routine product issues using independent judgment with the assistance of Engineering support when required. •Must have completed at least one 510K submission •Working knowledge of data collection, data analysis, evaluation, and scientific method. •Engineering schematics/drawing/prints reading and interpretation. •Commitment to excellence and high standards •Excellent interpersonal, written English and oral communication skills •Excellent organizational, problem-solving, and analytical skills to lead to sound, timely decisions •Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines •Ability to analyze and resole non-routine regulatory issues using independent judgment.
Education and/or Special Training
•Bachelor's degree (B.S. or B.A.)/Masters degree in engineering or related science field preferred
