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Medical Product Development Online Course Instructor

We are no longer accepting applications for this recruitment

Description

Online teaching positions are now available in the Medical Product Development and Regulatory Affairs Certificate Programs. We are seeking qualified applicants possessing current knowledge and/or teaching experience in the topics of Process Validation for Medical Product Development, Regulatory Affairs, Application of ICH Guidelines, and Biomedical Business and Legal Management.

Specific Instructor Duties
•Develop and/or update course syllabi in consultation with the UCI Division of Continuing Education (DCE), Engineering, Sciences, and IT Programs Director as assigned and using approved syllabus template
•Prepare and deliver online course materials and learning assessments in the assigned format
•Utilize the Canvas Learning Management System as the course support platform
•Communicate teaching objectives and specific learning outcomes to students, and clearly outline the grading policies for the course
•Evaluate student achievement of specific learning outcomes, and assign grades
•Post final student grades to the transcript system by set deadlines
•Respond to student questions and learning needs in a timely manner
•Handle student inquiries about final grades and consult with Director as needed
•Stay current regarding the professional body of knowledge in the field of practice
•Participate in required orientations and complete mandatory training programs by deadlines established by UC Irvine
•Complete required administrative tasks in a timely manner including: completing all hiring paperwork; submitting updated quarterly syllabi; posting bio and photo on the UCI DCE course page; signing quarterly contract; ordering required texts
•Employ culturally competent teaching methodologies in the online classroom inclusive of both domestic and international student populations
•Allow students to review their final exams/papers for up to 13 months following the last class session
•Use subject-matter expertise and leverage additional resources appropriately to enhance the curriculum (i.e.: make arrangements for guest speakers, etc.)
•Design interactive and motivational online classroom activities to fully engage participants and to reinforce student learning (i.e.: design boards for labs, etc.)
•Update materials periodically, and regularly monitor course evaluations in order to make adjustments and improvements to the curriculum

Our curriculum is constantly updated and tailored to bring students the background, expertise, and business practices to remain competitive and advance their careers. Taught by qualified practitioners, our courses feature practical applications, underlying rationale, and current issues, all of which can be immediately utilized in and applied to our students’ work environments.

Part-time, temporary assignments are on an as-needed basis. This is an ONGOING recruitment. We accept part-time instructor applications all year long; when the division has a need to fill, they refer to the “pool” of applications on file. We are looking specifically for instructors who are qualified to teach the following course as early as spring quarter (beginning April 3rd, 2017).

Course Descriptions:
Process Validation for Medical Product Development (3 units)
Enhance your understanding of process validation and how it is applied to the development of medical products. Learn how to assess an appropriate level of process scrutiny to provide a high level of confidence for process validation. Increase your knowledge of validation project management; basic approach to process validation; validation criteria for facilities and utilities; sterilization; controls, automated processes, and computer systems. Case studies illustrate how critical processes are validated in the development of cardiovascular, ophthalmic, and intravenous devices.

Biomedical Business and Legal Management Essentials (3 units)
Increase your knowledge of business and legal issues in the biomedical industry. Participants will learn to discern the rationale behind policies and procedures in a highly regulated industry. A top down approach is taken to introduce broad business and legal concepts and relating them specifically to design, development, and commercialization of medical device and pharmaceutical products. Topics include: corporate structure, corporate formation; and early stage financing, contracts, licensing, formation, intellectual property, due diligence and sale.

Regulatory Affairs for Post-Market Approval (2 units)
Learn how to continuously evaluate and perform periodic reporting on the safety, effectiveness, and reliability of a medical device for its intended use. Utilizing design controls practices and procedures, participants learn “design transfer” from research and development to manufacturing. Increase your knowledge on managing regulatory affairs activities for engineering design modifications, post approval studies, and after-market product changes. Participants learn how to recognize the regulatory pathway for changes in labeling, manufacturing process, design, sterilization, packaging, material and vendor; changes due to customer complaints, product recall or field corrective action.

Application of ICH Guidelines - Regulatory Strategy Development and Dossier Preparation
A well-planned regulatory strategy formulated in the early stages of product development is critical for a product’s success. This course will examine the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines. Discover how ICH guidelines guide the development of regulatory strategies for product development. Learn how to apply ICH Guidelines for preparation of market authorization application dossiers. Exploration of IC guidelines during this course will include those establishing the chemistry, manufacturing, and controls data needed to support investigational and marketing applications. The ICH guidelines establishing the required structure and content of the Common Technical Document (CTD) are also covered. This class emphasizes the practical application of ICH guidelines to help build a successful dossier for submission to regulatory authorities.

To apply for this position, please click this link: https://recruit.ap.uci.edu/apply/JPF03792

Individuals hired to teach these courses must understand that all such agreements with the University are made on a course-by-course basis and that the Instructor will be made no guarantee of continual involvement with the University in any capacity.

Qualifications

Basic
•Advanced degree from an accredited institution

Additional

•Current knowledge of and demonstrated proficiency in subject area
•Must be committed to the highest level of academic standards and integrity
•Highly effective oral and written communication skills, including the ability to convey conceptual and complex ideas and information
•Highly effective interpersonal skills
•Proficiency in (or willingness to learn) the use of instructional technology and online teaching tools
•Current participation in professional associations
•Comfort in dealing with international professionals and students

Preferred
•Experience designing/revising curriculum and measuring student performance
•College-level teaching experience (or the corporate equivalent)
•Prior online teaching

The University of California, Irvine is an Equal Opportunity/Affirmative Action Employer advancing inclusive excellence. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected categories covered by the UC nondiscrimination policy.

Job location

Online

Learn More

More information about this recruitment: https://ce.uci.edu/

Requirements

Document requirements
Reference requirements
  • 3 required (contact information only)