Compliance Engineer III

Job Description :

Work Schedule

Environmental Conditions

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.

Position Summary

Ensures that all products meet applicable regional and/or international regulatory and compliance requirements by guiding design, documentation, and market authorization activities throughout the product lifecycle.

• Decision-maker and approver of documentation within the area of responsibility.
• Reviewer of declarations of conformity, market-specific documentation and if required regulatory submissions.
• Authority to interpret and implement applicable international, regional, and national law, regulatory requirements and standards.
• Authorized to initiate and approve product compliance activities, including risk assessments, labeling updates, and conformity evaluations.

Roles & Responsibilities

• Ensure that product design and development activities comply with applicable regulatory frameworks (e.g., EU MDR, IVDR, FDA 21 CFR, ISO 13485, IEC 61010, and other relevant standards).
• Monitor, interpret, and communicate changes in global regulatory and product safety requirements to relevant stakeholders.
• Develop and maintain compliance strategies and documentation to support product registration and market access in all operational regions.
• Support design and engineering teams to integrate regulatory requirements early in the product lifecycle.
• Coordinate preparation and submission of technical files, declarations of conformity, and related documentation for regulatory purposes from an R&D aspect.
• Collaborate cross-functionally with R&D, Quality Assurance, and Manufacturing to ensure sustained compliance throughout the product lifecycle.
• Participate in internal and external audits, inspections, and regulatory reviews, ensuring timely and accurate responses.
• Support post-market surveillance, vigilance, and reporting activities related to product compliance.
• Develop and enhance current processes related to product compliance. Support implementation of any updated/created processes and if relevant - host trainings in new ways of working to ensure efficiency and consistency across product lines.

Required Qualifications

• Bachelor or Master of Science in Engineering, Regulatory Affairs, Quality Management, Life Sciences, or related technical discipline.
• Minimum of 3-5 years of experience in regulatory affairs or product compliance within a regulated industry (preferably medical device, pharmaceutical or life science).
• Strong understanding of international product regulatory frameworks (e.g., EU MDR/IVDR, FDA 21 CFR, ISO 13485, ISO 14971, IEC 61010 and related standards).
• Experience with conformity assessment procedures, technical documentation, and regulatory submissions.

Miscellaneous Qualifications/Requirements

• Professional-level proficiency in written and spoken English.
• Ability to analyze and interpret complex regulatory texts and translate them into actionable design and process requirements.
• Capable of working independently while maintaining effective collaboration in cross-functional and matrix organizations.
• Strong organizational and time management skills.
• Excellent communication and presentation skills, with the ability to influence and guide technical and non-technical stakeholders.
• Structured, analytical, and results-driven mindset, with demonstrated problem-solving capability in regulatory or compliance contexts.

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!