Direct and prepare regulatory submissions as required for global approvals for IVD’s, including preparation of reports and interaction with regulatory officials as required.
Review product labelling and promotional literature for regulatory compliance.
Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing submission strategies, policies and procedures that ensure submission 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 labelling 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.
Management of direct employees.
At least 5-8 years of relevant professional experience required.
Extensive experience in the medical device/biotech or pharma 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.
Possess a working knowledge of the MDD and IVDD, applicable ISO standards, and ideally US medical device/IVD regulation.
Very good knowledge of English.
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.