| Opportunity to develop a growing team and make your mark on a growing company, involving yourself with the overall strategy and putting yourself into a situation to move towards senior director level. Main tasks (primary responsibilities) of the position: Direct and prepare regulatory submissions as required for global approvals for IVD s, including preparation of reports and interaction with regulatory officials as required
Manage a highly effective Regulatory Affairs function, with line management responsibility for Senior Managers
Review product labeling and promotional literature for regulatory compliance
Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with global regulatory agencies
Interface with regulatory agencies for inquiries and issues
Review R&D protocols and technical reports and other company documents (including labeling and marketing materials, when applicable) for use in regulatory submissions and in response to queries from regulatory authorities
Oversee and direct the preparation of regulatory documentation for country-specific registrations
Develop regulatory process SOPs relevant for registration of IVD products or other regulatory aspects Position requirements, qualifications and experiences: Extensive experience in the medical device industry, preferably with IVD experience, and extensive regulatory experience, preferably in the area of IVDs, including the preparation and submission of 510(k), PMAs, PLAs, ELAs, IND, IDE, CE Design Dossiers, CE Technical Files, and CLIA Certificate applications.
A proven ability to lead and influence colleagues successfully in a dynamic and evolving matrix environment.
Possess a working knowledge of the MDD and IVDD, applicable ISO standards, and US medical device/IVD regulation.
Demonstrated organisational, planning and prioritising abilities, as well as strong technical writing ability;
Must be able to exercise sound judgment for high-level decision-making responsibilities |
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