Regulatory Affairs Analyst
Sunquest Information Systems, Inc. provides diagnostic and laboratory information systems to healthcare providers worldwide. Sunquest is the chosen partner for more than 1,700 laboratories and over 300,000 end users. For more than 30 years, Sunquest has delivered interoperable solutions that optimize business resources and improve the quality of patient care.
Sunquest makes healthcare smarter and patients safer by bringing highly reliable, timely, and relevant diagnostic information to the point of care.
Essential Functions:
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)
One to three 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.
PHYSICAL REQUIREMENTS:
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.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Sunquest makes healthcare smarter and patients safer by bringing highly reliable, timely, and relevant diagnostic information to the point of care.
Essential Functions:
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)
One to three 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.
PHYSICAL REQUIREMENTS:
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.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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