Review and update of EU MDR/IVDR Technical Files and support to the RA mailbox regarding Change Orders, product related questions, complaints and non-conformities, etc. for sites in Tijuana, Monterrey and Roskilde.
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Work for regulatory activities in cooperation with the existing RA team and Sr RA Manager
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Support product development by facilitating globally focused regulatory strategies to drive market access.
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Draft regulatory plans and verification reports to ensure products meet regulatory requirements in all target market regions.
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Responsible for updating the CE technical files for medical products.
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Participate in and ensure follow up on customer requests in the RA mailbox.
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Review and approve product development reports, non-conformance reports, product changes, label content and new product data.
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Provide general quality support to the organization e.g. TrackWise, complaint, observations, CAPA, NC, CO’s, product registration and technical file questions etc.
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Additionally, be part of the risk evaluation in related quality tasks.
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Optimize, document and implement RA processes in QMS regarding regulatory procedures.
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Support external and internal audits. E.g. participate in the Notified Body audit back office to provide documentation and explanation for the technical file documentation.
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Minimum BA/BS degree in a scientific or engineering field (preferred: biology, chemistry, material science, polymer science).
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At least 2 years of experience in a regulated industry (pharmaceutical or medical device).
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Strong working knowledge of US and EU Medical Device and In vitro Diagnostic requirements
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Analytical mind-set and a great ability to learn new professional fields and business processes
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Great ability to structured and goal-oriented manner
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Excellent communication and team-building skills
