Regulatory Affairs Officer
- Onderzoek wetenschap
Pantex Holland B V
De Functie: Als RAO ben je verantwoordelijk voor het verkrijgen en onderhouden van registraties of productlicenties in de verschillende exportlanden. Dit houdt o.a. in: - Mede bepalen van...
Locatie: Duizel
Datum: 2011-10-15 00:00:00.000
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| Regulatory Affairs Officer De Functie: Als RAO ben je verantwoordelijk voor het verkrijgen en onderhouden van registraties of productlicenties in de verschillende exportlanden. Dit houdt o.a. in: - Mede bepalen van... |
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| Regulatory Affairs Officer De Functie: Als RAO ben je verantwoordelijk voor het verkrijgen en onderhouden van registraties of productlicenties in de verschillende exportlanden. Dit houdt o.a. in: - Mede bepalen van... Vergelijken deze vacature » |
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| Regulatory Affairs Specialist (cmc) FunctieomschrijvingVoor onze opdrachtgever, een internationale farmaceutische organisatie, zijn wij met spoed op zoek naar 2Regulatory Affairs Specialisten / ProductspecialistenDe afdeling is verantwoordelijk voor de regulatoire taken met betrekking ... Vergelijken deze vacature » |
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| Regulatory ComplianceandKnowledge Officer At Claymount In this new position it is your job to collect all necessary information about country-specific regulations and procedures which need to be met in order to get new components certified and admitted. You will be in close contact to certification authorities and regulatory bodies (e.g. the FDA in the US). You will be doing research which compulsory test protocols need to be implemented and you will seek and contract test houses. You will inform the Group Management about initiatives, budgets and time schedules, which are required for realizing market admittance. It will be your responsibility to create an organization-wide accessible knowledge system, take care of all necessary documentation and secure that people in the organization comply with the latest regulations and work processes. You will report to the CTO. Your profile For you it is a challenge to build a sound knowledge base by thorough investigation, accurate and systematic recording and organization-wide implementation. You feel rewarded when your efforts result in faster market introductions; it gives you energy to facilitate people within Claymount in making their daily work easier. Your independent approach and convincing communication skills support your professional, advisory role towards Group Management and your expertise role towards technical professionals. At least a Bachelor degree (technical studies). At least five years of professional experience in an independent, international compliance position. It is a plus if you are familiar with the medical equipment market and/or X-ray technologies. You are fluent in English. We offer A new role in a fast growing organization. The opportunity to build your own professional expert position independently. The challenge to make the difference in supporting the organization in its expansion. An international setting, where you can use and build your worldwide in- and external network. The possibility to travel. You will be working in a beautiful, tranquil part of the Netherlands (Achterhoek), for a well equipped and ambitious company with approx. 180 employees (65 in Dinxperlo). Pleasant, professional colleagues who appreciate working according to standards and deliver quality products. Vergelijken deze vacature » |
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| Senior Qa Officer The Quality Assurance Department is comprised of several departments designed to oversee manufacturing activities in accordance with current Good Manufacturing Practices (cGMP), namely storage, testing, processing, packaging, release, holding, labeling and distribution activities. The Senior Quality Assurance Officer is mainly responsible to support and drive compliant and efficient processes and systems that meet total company objectives while at same time assures work practices, procedures, processes and systems are adequately controlled such that cGMP are sustained in dynamic regulatory environment. Your tasks and responsibilities are providing internal consultation related to cGMP, providing communications with department management to analyze system/process performance and overseeing several systems/processes and to determine effectiveness of those systems and processes. You have ownership of the systems/processes during a regulatory inspection. The Sr QA Officer coaches and trains others in Quality Operations and Supply Chain accountable for proper use the quality management systems. Furthermore you will identify integration points between work practices and quality management systems and assure adequate controls, documentation and traceability are established based on risk assessments. The position concerns a temporary period, until the end of December 2011 for 40 hours/week. Vergelijken deze vacature » |
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