Regulatory Safety and Compliance Engineer

Location: Brno, Czechia

Category: Quality & Regulatory

Employment Type: Full time

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

DESCRIPTION:

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. The following responsibilities are relevant in this role:

• 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 Regulation, 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.