Product Compliance Specialist
vor 2 Monaten
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.
**Location/Division Specific Information**
We are a research, development, and production site in Bremen, currently with about 500 employees, whose “high-end” measurement and analysis instruments (mass spectrometers) are used in research and science worldwide. Our innovative products in the fields of Life Sciences MS and Inorganic MS, as well as Trace Elemental Analysis, are among the leading products globally in their respective markets.
**Discover Impactful Work**:
As part of our team in Bremen, you will:
- Independently monitor standards and regulations to maintain required product compliance.
- Define and conduct all necessary internal and external tests to meet relevant standards and regulations.
- Analyze and evaluate deviations and their impact on existing or developing products.
- Coordinate and follow up on identified gaps to create Technical Product Files (e.g., CE Technical File).
- Maintain and continually improve development and production processes to meet all relevant standards and regulations.
- Adapt responsible processes to changing standards, regulations, and directives.
- Collaborate with other internal compliance experts.
**Keys to Success**:
**Education**
- Completed higher education in Mechanical Engineering or a 2-year technical college education with several years of professional experience and additional training.
**Experience**
- Knowledge of standards, guidelines, and regulations (e.g., EN 61010, EN 63000, Low Voltage Directive, Machinery Regulation).
**Knowledge, Skills, Abilities**
- Proficiency in Power BI and other reporting tools is desirable.
- Excellent time management.
- Structured, independent, and meticulous working style.
- Ability to analyze and interpret standards, technical regulations, or other frameworks.
- Proficient in German and English.
**What we offer**:
- This role is part time 25hrs/ week
- Employment with an innovative, future-oriented organization
- Outstanding career and development prospects
- Excellent Work-Life-Balance
- Company pension scheme and other fringe benefits
- Exciting company culture which stands for integrity, intensity, involvement, and innovation
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or any other legally protected status.
Agency notice
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