Senior 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**:
Are you passionate about compliance and engineering? Do you excel in dynamic environments where your attention to detail and expertise can have a significant impact? Join our team at Thermo Fisher Scientific Inc. as a Senior Product Compliance Specialist (Electronics) (m/w/d). Your role will be vital in ensuring our products adhere to all required standards and regulations.
**A day in the Life**:
- As a Senior Product Compliance Specialist, you will play a crucial role in development and product modification projects within the AAT (GC/GCMS/TEA) division. Your daily tasks will involve:
- Conducting independent research on standards and guidelines to ensure required compliances such as CE and NRTL.
- Completing all required internal and external tests to meet applicable standards and guidelines.
- Coordinating third-party tests and tracking follow-up actions.
- Analyzing and evaluating deviations and their impact on projects and the product development process.
- Crafting technical product files (e.g., CE Technical File) in your role as the CE Officer for the AAT Business Unit.
- Continuously improving development and production processes to meet all relevant standards and guidelines.
- Adapting responsible processes to changing standards, guidelines, and regulations.
- Serving as the internal point of contact for all questions regarding product compliance in the product development and modification process.
- Coordinating with other product compliance professionals and quality teams within the division.
- Addressing cross-location compliance questions and coordinating with product compliance officers at other Thermo Fisher (AAT) locations.
**Keys to Success**:
**Education**
- Completed higher education or studies in Electrical Engineering, or a 2-year technical school education with several years of professional experience and additional training.
**Experience**
- Knowledge of standards, guidelines, and regulations (e.g., EN 61010, EN 60601, Low Voltage Directive, Machinery and IVD Regulation
- Additional training as a Functional Safety Engineer is desirable.
- Additional training as a CE Officer is desirable.
**Knowledge, Skills, Abilities**
- Excellent time management skills.
- Strong communication abilities and high social competence.
- Structured, independent, and conscientious working style.
- Ability to analyze and interpret standards, technical regulations, or other rules.
- Very good command of German and English.
**What we offer**:
- 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
- Relocation expenses
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.
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