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Regulatory Affairs Specialist II (Can be a fully remote position in the United States)
JOB SUMMARY:   With minimal supervision, responsible for coordination and preparation of document packages for regulatory submissions from all areas of the company. Compiles all materials required for submissions, license renewals and annual registrations to ensure the sale ability of Celera products domestically (United States) and internationally (EU/Canada/ROW). Reviews and recommends changes for labeling, marketing literature and clinical protocols for regulatory compliance to international/recognized standards and procedures. Keeps abreast of all regulatory registration regulations, approval processes, standards and changes. Participates in the interactions with representatives from the Food and Drug Administration (FDA), Authorized Representative, Competent


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