Title: Site Contract Specialist (m/f/d) Location: Remote Germany Full time Remote As part of our global team, you’ll have the opportunity to prepare and negotiate contracts, as well as finalize the contract process. As a Site Contract Specialist, you'll liaise and establish effective relationships with sites and internal functional teams. You will ensure quality, objectivity, and risk analysis in the efficient delivery of contracts. What You’ll Do: - Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process. - Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes. - Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations. - Ensures compliance of budgetary guidance, templates and process. - Identifies and assesses legal, financial and operational risks and escalates to appropriate level of the organization per established processes. - Provides recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels. - Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation. - Achieve target cycle times for site activations. - Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate. Education and Experience Requirements: - Bachelor's degree or equivalent and relevant formal academic / vocational qualification - Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years). Knowledge, Skills, and Abilities: - Good understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws - Demonstrated ability to apply basic principles of investigator grant negotiation - General understanding of business and financial principles that related to service agreements - Effective communication skills (verbal & written) in English and local language - Fluency in English and German language (minimum C1 level) - Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters - Demonstrated ability in attention to detail - Excellent analytical and decision based thinking skills - Understanding of the pharmaceutical product development process and involvement of CROs - Able to work independently or in a team environment - Good organizational and time management skills - Working knowledge of PPD SOP & WPDs - Able to organize competing priorities logically and review outstanding contractual risk and issues - Able to effectively use automated systems and computerized applications - Ability to demonstrate a customer focused style of communication, problem solving and collaboration Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Title: Regulatory Specialist / Engineer III, RA Location: Remote Mexico Full time Remote Regulatory Specialist is overall responsible for supporting RA with the tasks described as below. Furthermore, the employee shall provide continuous regulatory support to the organization with review and update of EU MDR/IVDR Technical Files and support to the RA mailbox regarding Change Orders, product related questions, complaints and non-conformities, etc. for sites in Tijuana, Monterrey and Roskilde. Key Responsibilities: - Work for regulatory activities in cooperation with the existing RA team and Sr RA Manager - Support product development by facilitating globally focused regulatory strategies to drive market access. - Draft regulatory plans and verification reports to ensure products meet regulatory requirements in all target market regions. - Responsible for updating the CE technical files for medical products. - Participate in and ensure follow up on customer requests in the RA mailbox. - Review and approve product development reports, non-conformance reports, product changes, label content and new product data. - Provide general quality support to the organization e.g. TrackWise, complaint, observations, CAPA, NC, CO’s, product registration and technical file questions etc. - Additionally, be part of the risk evaluation in related quality tasks. - Optimize, document and implement RA processes in QMS regarding regulatory procedures. - Support external and internal audits. E.g. participate in the Notified Body audit back office to provide documentation and explanation for the technical file documentation. Minimum Requirements/Qualifications: - Minimum BA/BS degree in a scientific or engineering field (preferred: biology, chemistry, material science, polymer science). - At least 2 years of experience in a regulated industry (pharmaceutical or medical device). - Strong working knowledge of US and EU Medical Device and In vitro Diagnostic requirements - Analytical mind-set and a great ability to learn new professional fields and business processes - Great ability to structured and goal-oriented manner - Excellent communication and team-building skills Successful Candidate Will Possess - A positive approach and motivated by challenges - Team-player mentality - Dedicated with the ability to handle tasks independently - Flexibility to handle shifting priorities - Confidence in collaborating with colleagues at all levels - Strong written communication skills, with technical writing experience being a plus - Excellent critical thinking and decision-making skills - A continuous improvement approach - Innovative problem-solving ability - Strong organizational skills with attention to detail How will you make an impact? The Regulatory Specialist will support the Laboratory Plastics Essentials business by working closely with global manufacturing sites including locations in Tijuana (MX), Monterrey (MX) and Roskilde (DE) to ensure overall product safety and regulatory compliance. This position will be responsible for maintaining and updating Technical Documentation on regulated products and ensuring continuous improvement as it relates to changes in global standards and regulations. In addition, the RA specialist will assist with risk analysis or health hazard assessments for product recalls or field actions relating to a non-conforming product. The RA Specialist will also act as a regulatory consultant to ensure all products comply global and regional regulations and market needs (REACH/SVHC, California Proposition 65, RoHS). What will you do? - Ensure availability of up-to-date technical documentation and Standard Operating Procedures - Work together with LPE global teams for supporting customer requests with related RA mailboxes - Work with the global environmental compliance team to oversee the management of compliance information for all sourced materials, components and finished goods - Support international registrations with related technical documentation - Function as an RA subject matter expert on new product introductions, capacity expansion projects and custom product development and manufacturing - Complete timely regulatory safety evaluations on customer complaints and manufacturing non-conformance activities for regulated products - Provide regulatory input to QA in Deviations, CAPAs, Management Review and complaints - Provide guidance regarding regulatory and performance test requirements for product claims and the design verification and validation of products (including sterilization, biocompatibility, labelling, clinical, and packaging validation)

• Serve as the primary technical resource for enterprise customers during complex troubleshooting, onboarding, and expansion • Code Fluency: Comfortable reading source code to understand how a product behaves • Own complex customer issues across Kubernetes (k8s), ECS, Docker, cloud platforms, and on-premise/hybrid environments • Perform root-cause analysis on pipeline failures, deployment issues, runner/agent connectivity, and secrets management errors • Debug infrastructure automation, execution logs, and metrics data across CloudWatch, Google Cloud Operations/Stackdriver, and Azure Monitor • Lead incident triage during escalations, coordinate cross-functionally, and deliver clear technical findings to Engineering • Reproduce edge-case bugs with clean reproduction steps and drive resolution in partnership with Product and Engineering • Develop and maintain runbooks, troubleshooting guides, and customer-facing playbooks

• Be on the front-lines and ensure our customers increase the safety, efficiency, and sustainability of their operations with our IoT platform • Manage the deployment of Samsara technology to customers, enabling customers to achieve quick time to value in their investment • Create launch plans and a roadmap to increase product usage • Track implementation progress, participation, product adoption, and account health • Run training sessions, demonstrate Samsara’s technology, and work through challenges with customers and day-to-day users of the system across numerous use cases • Juggle multiple customer engagements in parallel and work cross-functionally to deliver an exceptional experience for our customers • Deeply understand the Samsara platform’s capabilities and explain them to customers of all types • Champion, role model, and embed Samsara’s cultural principles (Focus on Customer Success, Build for the Long Term, Adopt a growth mindset, Be inclusive and Win as a team) as we scale globally and across new offices