OverviewThis job is with Thermo Fisher Scientific, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community.
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Please do not contact the recruiter directly.Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale.
Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer.
We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.DescriptionJoin our collaborative team as a Regulatory Affairs Specialist I at Thermo Fisher Scientific, where you'll contribute to ensuring our products meet global regulatory requirements and help make the world healthier, cleaner, and safer.
You'll work with cross-functional teams to manage product registrations, maintain compliance documentation, and support regulatory submissions across international markets.
This position offers excellent professional development opportunities within our innovative environment focused on serving science.As a valuable member of our Regulatory Affairs team, you'll compile technical documentation, review regulatory requirements, and support product lifecycle management from initial registration through post-market activities. xjrgpwk
You'll collaborate with Quality Assurance, MSAT, Commercial teams, and regulatory authorities to ensure compliance while facilitating efficient product launches and maintaining existing approvals.RequirementsBachelor's Degree requiredPreferred Fields of Study: Life Sciences, Chemistry, Pharmacy, Engineering, or related scientific fieldAdditional qualifications in Quality Management or Regulatory Affairs advantageousExperience with regulatory submissions and documentation managementStrong technical writing and documentation skillsProficiency in Microsoft Office applications (Word, Excel, PowerPoint)Excellent organizational abilities and attention to detailStrong analytical and problem-solving capabilitiesEffective verbal and written communication skills in EnglishAbility to work both independently and collaboratively in a matrix environmentExperience with regulatory databases and submission systems preferredKnowledge of GMP, ISO 13485, and quality management systemsAbility to manage multiple projects and meet deadlinesCustomer-focused mindset with strong interpersonal skillsDemonstrates company values of Integrity, Intensity, Innovation, and Involvement
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