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Global Compliance Specialist
hace 2 meses
Job Title: Global Compliance Specialist
Job Summary:
We are seeking an experienced Compliance Specialist to join our team at Thermo Fisher Scientific Inc. in a global role. The successful candidate will be responsible for implementing regulations and legislation in our product development, interpreting requirements into technical specifications, educating project teams on compliance, and supervising compliance implementation.
Key Responsibilities:
- Be aware of directives and regulations such as electrical safety, EMC, Radio Equipment, RoHS, and related standards relevant to instruments.
- Overall responsibility of product safety and compliance (DoC).
- Participate in development projects as a member of the team, responsible for the overall compliance of the new design to any regulatory requirements.
- Participate in project reviews, responsible for the overall compliance of the new design to any regulatory requirements.
- Participate in the update and development of relevant SOPs to improve the quality of testing and documentation.
- Coordinate official testing done by authorized organizations.
- Collect and maintain compliance files (CE-mark, NRTL, CCC, etc.).
- Participate in internal and external audits.
Requirements:
- Minimum of 4 years of experience in the Electrical/Biotechnology/Life Sciences industry, with a minimum of 2 years of experience in Regulatory/Quality or an applicable Technical field.
- Experience with electrical safety, EMC, radio directive implementation.
- Working knowledge of ISO 9001 and regulatory requirements for electrical devices.
- Experience with risk management and different risk techniques is highly desirable.
- Strong critical thinking skills with attention to detail and ability to maintain visibility of the greater picture.
- Organized, structured, and decisive with the ability and willingness to work in ambiguous situations.
- Good strong communication skills adept with communication at all levels as well as with customers/stakeholders in a professional and effective manner.
- Committed and self-driven with a positive mindset, flexibility, and persistence.
