Regulatory Safety and Compliance Engineer v Brno –… - Jobeax
Popis nabídky
Regulatory Safety and Compliance Engineer v Brno – Černovice, Česko
Thermo Fisher Scientific
Na dálkuPráce odkudkoli
Czech Republic
Regulatory Safety and Compliance Engineer v Brno – Černovice, Česko is listed on Jobeax. Browse 80,000+ vacancies available.
As 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.
Join our collaborative team at Thermo Fisher Scientific as a Regulatory Safety and Compliance Engineer, where you'll contribute to ensuring product safety and regulatory compliance during design and development projects.
Responsibilities:
Evaluate and interpret World-Wide regulations and standards, guiding design teams to ensure complaint end-product solutions are archived.
Perform technical product design reviews to ensure proposed solutions are compliant with applicable safety and product regulatory requirements.
Coordinate product safety testing for new and existing products to validate safety and regulatory compliance with applicable global requirements.
Serve as primary interface with safety test labs, reviewing test results, address compliance issues and approving test reports.
Creation and ensuring completion of regulatory safety and compliance test plans, to include required standards, test specifications, estimated cost, turn-around time and submittal strategy for targeted markets.
Review and approve user manuals product regulatory and safety labelling, including data sheets and user manuals.
Review engineering changes for regulatory safety and compliance implications
Review 3rd party items for the impact on product safety and compliance.
Support business units, local factories and service in product safety and compliance
Contribute to defining product safety design guidelines and embedding this in the Integrated Management System.
REQUIREMENTS:
BS in Electrical Engineering or related scientific discipline or min. 10 years related experience, or equivalent combination of education and experience, in safety related discipline.
Proven experience to judge engineering solutions on their product safety impact in multiple areas including mechanics, EMC, electrical, electronic, chemical, X-ray and pressure vessel.
Familiar with applicable OSHA and CE regulations, Machinery directive, EMC directive, SEMI S2 & S8, NFPA79, Euratom ionizing Radiation directive and Pressure Equipment Directive.
Thorough understanding of UL 61010-1:2012 / ANSI/ISA-61010-1 standard with proven expertise in evaluating and testing products against the specified design requirements.
Experience with certifications bodies such as UL/TUV/Semi S2 auditors
Working knowledge of the capital equipment industry.
Willingness and ability to travel up to 25% as required.
Strong problem-solving and analytical skills, with a keen attention to detail.
Proven ability to transform complex challenges into practical and effective solutions.
Excellent written and verbal communication skills.
Demonstrated ability to manage and contribute to multiple international projects simultaneously.
Solid understanding of data integrity requirements and computerized system compliance.
Ability to review, evaluate, and approve technical documentation, protocols, and reports.
Self-motivated professional with a proactive approach, strong sense of accountability, and a collaborative team-oriented mindset.
How do we motivate you?
Work with us and be an important part of a company developing cutting-edge technologies for a scientific customers worldwide
Hackerspace room equipped with VR headset, Recording studio for your videos, music or podcasts, Lego Mindstorms, 3D printer, Arduino and much more!
Flexible working hours to better balance your personal life. 25 days of vacation and 5 sick days/year
Possibility to combine work from site and home office (1 day per week)
Financial benefits - annual bonus, pension insurance allowance, possibility of life or health insurance for better prices
Mobile tariff for you and family members for great prices
Free Multisport card
Meal allowance and company canteen with free fruit or vegetables every day
Modern work environment including relax zones, gym, outside playground and massages in the building
Open and friendly company spirit - we have a company rock band, various sport teams etc.
... specialists, contractors and other service providers. * Follow up on repairs and corrective actions, verify their completion and maintain relevant inspection, incident and maintenance records. * Communicate site safety rules to tenants, contractors, drivers and other warehouse users, follow up on non-compliance and escalate serious ...
... quality control processes allow only products meeting company specifications to be received and distributed - Drive compliance with food safety, consumer protection and operational standards requirements across the business - Monitor and implement new legislation related to food safety, product safety and consumer protection ...
... Support compliance with EU and Czech chemical regulations (REACH, CLP, SCIP, PPWR, microplastics). - Maintain chemical inventories, Safety Data Sheets (SDS), and hazard communication records. - Review raw materials, products, and suppliers for regulatory compliance. - Support regulatory reporting, notifications, and customer ...
... Competencies - Strong commitment to safety, compliance, and integrity. - Effective collaboration across functions, sites, and cultures. - Data-driven decision making and clear communication of rationale and risk. - Continuous improvement mindset and determination for learning and growth in engineering quality and independent monitoring. ...
... automation solutions. Working with R&D, Quality, Production, and other departments, you'll optimize existing processes while ensuring consistent product quality and regulatory compliance. Your analytical skills and engineering expertise will help drive cost reductions, improve efficiencies, and enhance manufacturing capabilities ...
... activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects. - Advanced understanding of site engagement and ability ...
... and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. About the Role - The Senior Regulatory Affairs Specialist provides dedicated regulatory support ...
... documentation and workplace categorization in cooperation with public health authorities. - Supervise waste management processes, ensuring proper record-keeping and regulatory compliance. - Support Lean Manufacturing initiatives and contribute to continuous improvement in safety practices. - Ensure the correct use of personal ...
Do našeho týmu v Hořovicích hledáme nového kolegu nebo kolegyni se vzděláním v oblasti veteriny, medicíny, farmacie, chemie nebo přírodních věd, kterého láká svět registrací veterinárních léčiv. Hledáme především pečlivého člověka se zájmem o tuto odbornou oblast a chutí učit se nové věci. Co Vás u nás čeká?
... creation and implementation of security solutions and programs. - Regulatory Compliance: Brings advanced level skills to manage programs to establish, document and track compliance to industry and government standards and regulations, industry standards and customer and vendor contracts to communicate compliance requirements ...
... implementable recommendations. - Review and validate evidence provided by Cyber Security/Technology teams as part of control assurance activities, ensuring completeness and compliance with regulatory and industry standards. - Collaborate with Cyber Security and Technology teams to drive remediation of identified control gaps and ...
... activities - Ensure compliance with quality standards, validation processes, and laboratory procedures - Contribute to laboratory operations, efficiency improvements, and best practice implementation Requirements - University degree in a relevant engineering discipline such as Electronics Engineering, Computer Engineering, Physics, ...
... subcontractors to perform all imports and exports in compliance with the laws of the countries that have jurisdiction. In this capacity, the ability to understand and clearly communicate company trade compliance policies and the importance of import/export regulatory compliance is critical. While you are based in the Czech ...
... resolution. - Support the development and continuous improvement of adaptive monitoring strategies. - Coordinate monitoring activities based on study risk profile and operational priorities. - Contribute to maintaining high standards of patient safety, data integrity, and regulatory compliance. Required Qualifications - Degree ...
... processes, operating models and the business glossary across the organization - Support management in setting data-related priorities and strategy Data Quality & Compliance - Define and monitor data quality standards and KPIs - Ensure compliance with GDPR and internal policies - Support audit and regulatory requirements related ...
... situations and possible threats to the environment and safety at work. - Powers: - Interruption of work in the case of risk to health. Required qualifications and experience: - Bachelor or Master Degree in Electro-engineering - 5 years of electrical design in industrial environment - Attest “Vedouci Eletrotechnik” according ...
... first-hand insight into how health and safety is managed in an international engineering company. What You Will Do - Review and organize existing EHS documentation and processes - Map current workflows and identify improvement opportunities - Prepare and update procedures, checklists, and supporting documentation - Support the ...
... Myriad We are building a reliable and scalable AI-powered platform that allows US companies to put regulatory compliance on autopilot. At its core, Myriad is an engineering-driven company, founded by individuals with robust technical backgrounds, forged in Silicon Valley and molded by necessity. Myriad's software engineers are ...