Part Time Regulatory Affairs Specialist job vacancy

Vacancy expired!

RA Specialist Performs the coordination and preparation of documents for regulatory submissions for new products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance. Monitors and improves tracking/control systems. Keeps abreast of regulatory procedures and changes. Recommends strategies for earliest possible approvals of clinical trials applications.

Responsibilities:May perform some or all of the following: Coordinate and prepare new in-vitro diagnostic (IVD) product document packages for regulatory submission to ensure compliance with regulations and company requirements. Prepare document packages for 510(k) premarket notifications, Health Canada licenses and EU Technical Files. Partner with marketing to assemble information required to support other international registrations including requests for Food and Drug Administration (FDA) Certificates to Foreign Government and Declarations of Conformity Create and maintain well organized regulatory files and archives for assigned product line by monitoring and tracking information, assuring accurate recordkeeping and preparing documents. Assess product and process changes for cleared 510(k) products and assist in determining if changes require updates or new product registrations Perform routine reviews of IVD product labeling, including promotional materials, as assigned; identify label changes that require higher level regulatory review Assist with reviews of verifications, validations and assessing the impact of change on product performance Provide technical guidance and regulatory guidance to cross-functional teams; compile, organize, and transcribe documentation for regulatory submissions, license renewals, and annual registrations Research regulatory information and data to support new product strategies Assist to maintain company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements, making updates as necessary Provides support for internal and Regulatory Agency audits General Regulatory support, as needed.Education / Experience: 2-3 years' experience Must be organized Outstanding oral and written communication skills required Proficient with MS Office

Benefits:

Health insurance
Casual Dress code
401k match

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EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Vacancy expired!

ID	#15192473
State	California
City	San diego
Job type	Contract
Salary	USD $40 - $45 per hour 40 - 45 per hour
Source	Real Staffing
Showed	2021-06-07
Date	2021-06-07
Deadline	2021-08-06
Category	Et cetera
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Job Details

Part Time Regulatory Affairs Specialist

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