Agencja zatrudnienia nr licencji 3260
Find your own at devire.pl
Location: Wrocław
Devire to międzynarodowa firma specjalizująca się w usługach rekrutacji, outsourcingu i employer brandingu. Od ponad 30 lat reprezentujemy wiodących pracodawców na rynku europejskim, prowadząc kompleksowe projekty poszukiwań menedżerów i wyspecjalizowanej kadry, wdrażając najnowsze rozwiązania z obszaru usług IT oraz wspierając w budowaniu wizerunku pracodawcy z wyboru.
Nasze biura zlokalizowane są w Warszawie, Wrocławiu, Poznaniu, Katowicach oraz Monachium, Frankfurcie, Pradze i Hradec Kralove.
Our client is one of the most prestigious biotechnology companies. We are looking for professionals who are ready to join the team of Quality in Wrocław.
Your Tasks:
• 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.
Our Client offers:
• Opportunity to work on international company
• Opportunity to work with experts
• Attractive salary and benefits (for example: private medical care, life insurance, language classes, etc.)
What we are looking for:
• At least 5-8 years of relevant professional experience required.
• 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.
• Possess a working knowledge of the MDD and IVDD, applicable ISO standards, and US medical device/IVD regulation.
• Very good knowledge of English.