Job Description

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. For more information, please visit www.thermofisher.com .

How will you make an impact?

We are looking for an experienced Compliance Specialist to join our Laboratory Plastics Essentials business in Monterrey, Mexico. Based in our facilities in APODACA MTY.

You will be implementing regulations and legislation in our product development, interpreting the requirements into numerical technical specifications, educating the project teams how to fulfill the requirements and supervising that the compliance is met. You will also have an important role in the planning new SOP's and guidance documents to facilitate proper testing and documentation as well as in coordinating standard official testing done outside the company by authorized organizations.

We are looking for proactive, self-driven, result oriented team player. You enjoy working with high technology products and want to develop yourself and the way of working. We offer motivating tasks in innovative working environment.

What will you do?

• 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 the relevant SOP's to improve the quality of testing and documentation

• Coordinate the official testing done by authorized organizations

• Collect the compliance files (CE-mark, NRTL, CCC, etc.)

• Keep the compliance files updated during the life span of the product (product changes, new requirements)

• Participate in internal and external audits

How will you get here?

• 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

Each one of our 130,000 extraordinary minds has a unique story to tell. It’s not just a career, it’s a chance to realise your best – professionally and personally.

Join us and contribute to our mission—enabling our customers to make the world healthier, cleaner and safer: http://jobs.thermofisher.com

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, protected veteran status, disability or any other legally protected status.