Involves review and approval of various product documentation such as labeling, specifications, and Certificates of Compliance
Show Me How
o Involves working with external suppliers for the purpose of setting up raw materials and ensuring proper compliance information is obtained.
o Perform duties in accordance with established company procedures and policies
o Develop, maintain and monitor programs for compliance with guidance and standards applicable to Single Use products, including changes to guidance and standards
o Maintain a good understanding of AAMI, UPS, EP, ISO, and ASTM guidance and standards applicable to the business, and keeping abreast with changes and developments
o Participate in department systems development initiatives to improve regulatory and quality efficiency and compliance
o Review and interpret scientific literature and summarize effectively in writing.
o Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness
o Preferably those with a Bachelor's degree with majors in Science or Engineering
o Preferably those with at least 3 years of relevant working experience in a regulatory setting with knowledge in the pharmaceutical/medical/healthcare industry.
o Computer/software proficiency in Microsoft Windows, Microsoft Office and Microsoft Outlook, or comparable systems, for the ability to prepare, edit, format and review documents to a high standard and to use in analysis, reports and communication.
o Professional oral and written communications, interpersonal skills and problem solving abilities.
o Good organizational skills and the ability to manage multiple tasks
o Ability to work independently Ability to lead teams
o Able to manage complex problems/projects by exercising independent decision making and analytical thinking skills within generally defined practices and policies
o Good attitude such as self-disciplined, self-motivated, active to take action and able to work under pressure
Non Negotiable Hiring Criteria:
o Bachelor's degree with majors in Science or Engineering or 6 years or experience
o 3 years of relevant working experience in a regulatory setting with knowledge in the pharmaceutical/medical/healthcare industry.
This position is not budgeted for relocation assistance.
Thermo Fisher Scientific Inc.