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Regulatory Restrictions / Product Discontinuation Analyst - Oferta z Jobs.pl

Administracja biurowa » Pracownik biurowy

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Regulatory Restrictions / Product Discontinuation Analyst

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  • Role and responsibilities: •Perform all job duties in full accordance with the Worldwide Policies on Information Asset Protection, maintain password(s) as Confidential, and protect Critical Business Information. •Comply with all applicable laws and regulations relating to client business activities and Policies / Procedures of the Health Care Compliance Program and Code of Conduct. •Coordinates related regulatory submissions such as EU Design Dossiers and Technical Files, IDE's, PMA's and 510(k)s, including those of a complex or strategic nature, and coordinates resources for larger regulatory submissions. •Provides expertise in foreign regulatory requirements •Guides conformance with applicable regulations •Defines data and information needed for regulatory approvals •Plans schedules for regulatory deliverables on a project and monitors project through completion •Assists in the development of best practices for Regulatory Affairs processes •Represents Regulatory Affairs on cross-functional project teams •Partners with other functions to define and obtain data to assist with regulatory submissions Requires skills and qualifications: •Minimum Educational Requirements - BS/BA is required, preferably in biological sciences, bioengineering, and/or related medical/health fields. Advanced degree preferred. oBS with minimum 4 years Regulatory Affairs experience in a regulated healthcare environment or industry; or minimum 2 years with advanced technical degree.oExperience with US FDA Regulations and European Medical Device Directives required. Experience in worldwide regulatory systems preferred. •Demonstrated expertise in medical device regulatory requirements and processes required •Project management skills by demonstrated competence in managing multiple projects simultaneously required •Equipment or Machines Used (Include WPM, if Applicable) Computer and associated software •Resolves regulatory issues. High level of decisions made using independent judgement and discretion within established guidelines to resolve regulatory issues


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