Registration specialist Medical Device (Part Time Contractor ) for Bausch & Lomb
Гібридна
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We are seeking a dedicated and experienced Contractor to support regulatory activitiesrelated to medical devices in Ukraine for Bausch & Lomb. In this part-time role, you will beresponsible for supporting the registration of new medical devices, conducting maintenanceactivities, and ensuring the completion of internal tasks. The ideal candidate will have astrong understanding of Ukrainian regulations, legislation and needs, as well as the ability towork closely with internal and external stakeholders.
KEY RESPONSIBILITIES:
- Perform medical device related submissions to Health Authorities / CompetentAuthorities / Certification Bodies;
- Work closely with and providing the necessary document/information to theinternal and external stakeholders;
- Preparation and organization of confirmation of production sites to therequirements of technical regulations;
- Collaborate with Global colleagues to obtain the documentation required for thelocal submission;
- Organization of translations of the documents and/or artworks;
- Verify artworks meet local requirements and preparation & implementation of thestickers for repackaging/relabelling operations when it is needed;
- Manage the data entry into the internal databases;
- Review and approve advertising and promotional materials;
- Conduct quality assessments for product changes;
- Support tenders;
- Work with distributors to assure regulatory compliance;
- Stay current on local regulations;
- Participate in regulatory policy and intelligence activities;
- Support regional/global projects as applicable;
- Participate in project planning and budgeting for Ukraine;
QUALIFICATIONS?
- Bachelor’s degree in science, engineering, pharmacy, medicine or related discipline?
- Strong knowledge of local medical device regulations;
- Capability to react quickly to changes in the regulatory environment;
- Self-motivated, detail-oriented and capable of working independently; Demonstrated ability in analytical reasoning and critical thinking skills;
- Fluent written and spoken English and Ukrainian;
- Experience working in cross-functional teams.
EXPERIENCE?
- At least 2 years of experience in regulatory affairs with Medical Devices.
Тетяна Лазоренко
Надійний HR-партнер для роботодавців та шукачів Більше 200 клієнтів
від 20 до 50 співробітників
з 2002 року на ринку
