Senior Platform Regulatory Specialist
Merit Medical
MINIMUM QUALIFICATIONS • Bachelors degree in life sciences, engineering, regulatory affairs or a related discipline. • 8 years of progressive Regulatory Affairs experience in the medical device industry. • Advanced English level • Prior experience in medical industry • Prior experience with health authorities and regulatory agencies such as U.S. FDA, European Notified Bodies, and Health Canada. • Demonstrated general knowledge of global medical device regulations, and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc., Design Controls, reviewing and approving project plans, qualification protocols/reports. Modern computer skills. • Relevant regulatory certifications (e.g., RAC) strongly preferred. COMPETENCIES • Project management • Written and Verbal Communication • Attention to Detail • Continuous Improvement • Analytical Skills • Strategic leadership • Team development • Results oriented • Integrity • Organization COMMENTS Infectious Control Risk Category III: The risk category explains whether or not employees are likely to come into contact with blood or body fluids while performing their jobs. Risk category III states employment and procedures that do not require exposure.
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