Regulatory Affairs Expert
SIRE Life Sciences®
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SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Medical Devices organisation, based in Slough United Kingdom.
The CompanyWe are looking for multiple Regulatory Affairs Experts in the Slough area.
Role DescriptionSupport Regulatory Affairs / Quality Assurance Support the QA responsible person:
ResponsibilitiesReview documents to enable the release or non-release of medicinal products, and release or withdrawal of medical devices for the market. Coordinate, prepare and submit Clinical Trial Applications (including notification of changes).
Search for information to support miscellaneous requests (from internal departments or from external stakeholders).
Ensure that marketing and logistic/Customer Service support processes are followed in compliance with the national and corporate requirements: e.g., approval of promotional material, customer procurement authorisation. Establish and revise documents in the Regulatory Affairs processes of the Quality Management System
Marketing Authorisation, coordinate and prepare submissions of Marketing Authorisation and applications to gain access to market of new medicinal products.
Collaborate with the Regulatory Affairs team. Maintain marketing authorisation of medicinal products to support the marketing strategy. Coordinate, prepare and submit variations and Marketing Authorisation Applications of medicinal products. Collaborate with the Regulatory Affairs team. Maintain project/variation tracking list, and generate reports of variation activities to the Head Market Access & Regulatory Affairs.
Vigilance In collaboration with the Regulatory Affairs team, handle quality complaints and adverse events, and record in global databases / tracking systems. Comply with legal, internal and Division requirements (appropriate documents and reporting tools, timelines).
RequirementsUniversity degree in pharmacy, medicine, biology, biochemistry, or chemistry and further education in Regulatory Affairs.
2 years or more experience in Regulatory Affairs and/or Quality Assurance from pharma or medical device industry, or health care .
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Riko Arends.