Regulatory Compliance Specialist
hace 2 semanas
**Regulatory Compliance in Product Development**
We are seeking an experienced Regulatory Compliance Specialist to join our team in Monterrey, Mexico. Based in our facilities in APODACA MTY, you will be responsible for implementing regulations and legislation in our product development, interpreting requirements into numerical technical specifications, educating project teams on fulfilling requirements, and supervising compliance.
**Key Responsibilities:**
- Be aware of directives and regulations like 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 compliance files (CE-mark, NRTL, CCC, etc.).
- Keep compliance files updated during the life span of the product (product changes, new requirements).
- Participate in internal and external audits.
**Requirements:**
- Minimum of 4 years Electrical/Biotechnology/Life Sciences industry experience, with a minimum of 2 years working 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 as well as 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.
At Thermo Fisher Scientific, we value our employees and offer a motivating work environment with innovative tasks.
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