Regulatory Affairs Specialist II
Location : Irvine, CA (Hybrid 3 days on site)
12 month Assignment
Pay Rate : $45-$49 / hr.
On behalf of our client a medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE Marked under the IVD Directive.
Job Responsibilities :
- Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template and it must clearly present the product, its characteristics and its expected performance to easily and fully understand the evidence of conformity.
- Must attend multiple weekly meetings which are intended to help address issues or questions regarding the technical files and keep the project manager informed on the progress of the work.
- Support the IVDR labeling conversion project which requires cross-functional participation and weekly group meetings to follow the conversion plan.
- Update the labeling conversion tracking log based on the monthly manufacturing schedule, the product fill dates, the associated product lot numbers and change requests numbers.
As needed, update labeling specifications to meet the IVDR requirements.
- Support the tasks to un-CE Mark selected products and track the work until the final labeling reflects the desired changes based on the labeling specification document.
- Other miscellaneous activities will include updating the technical file tracking log, notifying and tracking RA Regional notifications of labeling changes, and notifying the RA SAP restriction coordinator when specific product lots need to be restricted to prevent distribution of the product in specific areas of the world.
Education and Experience :
- Bachelor's degree in biochemistry, biology, medical technology or related fields and 3+years of experience in RA, and / or QA, R&D, Manufacturing or Project Management in the IVD industry.
- Knowledge of FDA, and CE marking requirements for IVD products is a plus
- Thorough knowledge of policies, practices and procedures related to RA.
Please submit a copy of your resume in Word or PDF format to be considered .
Regulatory Affairs Specialist
Regulatory Affairs Specialist II. On behalf of our client a medical device client, we are seeking a Regulatory Affair’s specialist that will support the EU's In Vitro Diagnostic Regulation (IVDR) transition activities that will impact the company’s products currently CE Marked under the IVD Directiv...
Regulatory Affairs Specialist
Job Description: Regulatory Affairs Specialist. Provide consultation and advice to regulatory specialists regarding change control and product development. Contribute to continuous improvement initiatives within the regulatory affairs function. Ability to interpret and apply regulatory requirements....
Sr. Specialist, Regulatory Affairs
Regulatory Affairs Specialist is responsible for preparing strategy for worldwide product approval timeline, submission activities focused on US/EU/Canada, and ensuring compliance to FDA and international regulatory agency requirements for. As a contributing member on product development and operati...
Senior Regulatory Affairs Specialist
Reporting directly to the CEO, the Senior Regulatory Specialist is responsible to plan, direct and coordinate global product registrations and lead regulatory submissions planning and execution; collaborate with Product Regulatory and Regional Regulatory Affairs colleagues to drive timely and accura...
Sr. Regulatory Affairs Specialist
Minimum five (5) years of experience in Regulatory Affairs. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg Practice, Good Practices training programs, SOP development, and GMP audits and inspections). Prepare and submit product registrations and submissi...
Regulatory Affairs Specialist
Support QA in executing compliance activities involving NCMRs, Process Deviations, MDRs to regulatory authorities. ...
Regulatory Affairs Specialist
The role of the Regulatory Affairs Specialist will be to support the global regulatory affairs of the business with a specialized focus on the United States. This position will be primarily responsible for obtaining and maintaining all necessary United States federal and state regulatory approvals f...
Senior Specialist, Regulatory Affairs, Critical Care
From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including p...
Prin Regulatory Affairs Specialist
He/She has responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions. Minimum of 7 years of experience medical device regulatory affairs Or advanced degree with a minimum of 5 years of experienc...
Regulatory Affairs Specialist (remote)
Medical manufacturer is hiring a Regulatory Affairs Specialist on a temporary basis. Previous medical device experience in a Regulatory Affairs capacity . ...