Dziękujemy za korzystanie z infoPraca.pl. Data wydruku 21/04/2019.
Oferta wyróżniona

Associate Manager Regulatory Affairs

Wrocław, dolnośląskie

Devire

Opis stanowiska pracy

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.

Prezentacja firmy

Devire to międzynarodowa firma rekrutacyjna, założona w Londynie w 1987 roku. Od 20 lat... reprezentujemy wiodących pracodawców na rynku europejskim prowadząc dla nich kompleksowe projekty poszukiwań menedżerów i wyspecjalizowanej kadry.

Poza rekrutacją świadczymy usługi Outsourcingu IT, Pracy Tymczasowej oraz Doradztwa HR. Nasze biura, zlokalizowane są w Warszawie, Wrocławiu, Poznaniu, Katowicach oraz Monachium i Frankfurcie. Jesteśmy częścią Devonshire Investment Group.
  Rozwiń

Informacje dodatkowe

Ostatnia aktualizacja:
18/04/2019
Wymiar etatu:
Pełny etat
Rodzaj umowy:
Na czas nieokreślony
Liczba wakatów:
1
Min. doświadczenie:
Bez doświadczenia
Min. wykształcenie:
Wyższe doktoranckie
Branża / kategoria:
Praca Laboratorium / Farmacja / Biotechnologia
Zapisz ofertę
do góry