Technical Application Specialist

Job Description:

• Key responsibilities

• 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

Requirements/Qualifications

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.