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Regulatory Affairs Analyst at Sunquest
Posted March 31, 2017
Sunquest Information Systems Inc.
3300 E. Sunrise Drive
Tucson, AZ 85718
Quality and Regulatory Affairs
Reports to (title):
Manager Regulatory Affairs
Career Band/Job Level:
Ensure domestic and international regulatory submission and reporting activities are completed in a timely manner so that full compliance with all applicable global regulatory requirements and internal product/project goals is maintained.
- Plans, coordinates and compiles regulatory submissions with minimal review and has sign-off responsibility to obtain and sustain commercial approval.
- Participates on project teams providing appropriate information on regulatory issues and obtaining needed information to meet regulation requirements.
- Reviews labeling for compliance with regulations and assures that claims are substantiated.
- Acts as the Regulatory liaison with FDA and international registrars on behalf of the organization to facilitate timely and favorable review of submissions and issues.
- Maintains current knowledge base on existing and emerging regulations, standards and guidance documents.
- Reviews new projects to determine the nature and scope of the regulatory involvement.
- Ensures organizational compliance with FDA regulations and international product registrations
- Works closely with product development on monitoring and compliance to product functional regulatory requirements, both national and international.
- Follows Regulatory Affairs SOPs.
- Other duties, as assigned, or as business needs require.
KNOWLEDGE, SKILLS, and ABILITIES
- Working knowledge and application of regulations and requirements with the ability to integrate into projects.
- Self-motivated and committed to a team approach
- Interpersonal and organizational skills
- Verbal and written skills to effectively communicate technical information
- Ability to manage changing priorities
EDUCATION and EXPERIENCE
- BA/BS in technical field or scientific discipline (biology, engineering, physical science)
- Four to six years minimum device industry experience.
- Three years minimum direct regulatory medical device submission experience with specific experience preparing 510(k), IDE and PMAA submissions.
- One year minimum international regulation experience.
- Development, interpretation or application experience with standards, guidelines and special controls.
- Experience reviewing promotional materials, labeling, and other documentation to assure regulatory compliance.
Work is performed in a normal office setting with minimal exposure to health or safety hazards; substantial time is spent working on a computer. Some travel may be required.
Sunquest’s policy is to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Applicants for U.S. based positions with Sunquest Information Systems must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire.
Overview of the company
Icagen partners with pharmaceutical and biotechnology companies to offer industry-leading scientific expertise and comprehensive access to technologies for ion channel and transporter drug discovery and development. With over 20 years of leadership in the ion channel field, the Icagen team offers an extensive track record of success in advancing molecules from drug discovery to clinical development across multiple therapeutic areas and ion channel classes.
Announcement received: 09.16.16
Start – Fall semester 2016 ASAP
Aim –Investigate strategies to increase muscle stem cell activity, both proliferation and differentiation, for future therapeutic intervention in muscular dystrophies. Objectives for each student are to gain experience in muscle stem cell culture and master experimentation in the early drug discovery space. Students will gain experience in advanced analytical techniques and skills relevant in assaying cellular biology function. Completion of these projects will aid student(s) in future academic or industry career paths.
Position 1 - Investigate cellular signaling pathways in isolated muscle stem cells (satellite cells).
The student will learn and perform muscle stem cell culturing and passaging. Multiple techniques will be utilized including differentiation of muscle stem cells, quantification of gene expression via quantitative Real-time PCR, quantification of protein expression via immunohistochemistry, and analysis of high content imaging. Project timeline is 3 months.
Position 2 - Investigate microRNA function in muscle stem cells.
The student will learn and perform muscle stem cell culturing and passaging. The student will utilize transient transfection methods to knock-down and inhibit expression of microRNA's of interest in muscle stem cell culture. Multiple techniques will be utilized including differentiation of muscle stem cells, quantification of protein expression via immunohistochemistry, and analysis of high content imaging. Project timeline is 3-6 months.
Position 3 - Investigate small molecule modulation of muscle stem cell biology, early drug development.
The student will learn and perform muscle stem cell culturing and passaging. The student will evaluate multiple small molecules targeting signaling pathways of interest. Multiple techniques will be utilized including differentiation of muscle stem cells, quantification of gene expression via quantitative Real-time PCR, quantification of protein expression via immunohistochemistry, and analysis of high content imaging. Project timeline is 3-6 months.
• Cell culture and aseptic technique
For more information, please contact:
L. Charlie Chen (CChen@icagen.com)
Senior Research Investigator
Icagen Tucson Research Center
2090 E Innovation Park Dr
Oro Valley, AZ 85755
Phone: (520) 544-6868