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 Neurovascular and Peripheral devices. Job duties :
- As a contributing member on product development and operation teams, at times act as sole representative from Regulatory to ensure regulatory compliance.
- Depending on product / project complexity, develop or assist in developing regulatory strategy for assigned projects.
- Execute the approved regulatory strategy for the assigned market(s).
- Write multiple technical sections of the regulatory submission or complete submission.
- Prepare and file regulatory submissions to ensure MicroVention devices are commercially available in the assigned market(s) based on the approved regulatory strategy.
- Document, consolidate, and maintain verbal and written communication with regulatory agencies.
- Maintain regulatory files and records.
- Review change order documents and assess regulatory impact of product changes on US, EU, Canada, and / or international regulatory strategy / submissions per MicroVention procedures.
- Review promotional material and labeling for regulatory compliance as assigned.
- Perform and / or oversee the technical publishing of submissions.
- Edit / revise Standard Operating Procedures (SOP) and Work Instructions (WI).
- Build team cohesiveness by influencing and supporting team members.
- Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
- Perform additional responsibilities as assigned.
Regulatory Affairs Specialist
JCW is working on an exciting search for Regulatory Affairs Specialist III for global Biotech who is expanding their growing team. Collaborate globally with various teams, including regional Regulatory Affairs Managers and a publishing teams. Regulatory Affairs experience in the life sciences indust...
Specialist I, Regulatory Affairs
This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Aides in the execution of the regulatory plan for the assigned market(s) based on the ...
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 3.
The Sr Regulatory Affairs Specialist is responsible for ensuring digital medical device regulatory clearance to enable market access by demonstrating compliance to applicable regulations through a registration dossier. Position: Sr Regulatory Affairs SpecialistLocation: Sunnyvale, CaliforniaPosition...
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 . ...
Regulatory Affairs Specialist
Support QA in executing compliance activities involving NCMRs, Process Deviations, MDRs to regulatory authorities. ...
Specialist, Regulatory Affairs
This position is responsible for assisting in obtaining regulatory approvals and ensuring compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements. Aides in the execution of the regulatory plan for the assigned market(s) based on the ...
Specialist, Regulatory Affairs
As a Specialist, Regulatory Affairs for TMTT, you will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US and EU, focusing on the paradigm shifting transcatheter tricuspid valve replacement therapy. From design to production, our Regulatory...
Associate Specialist- Post Market Regulatory Affairs
Bachelor’s degree in Engineering, Physical or Biological Sciences, Regulatory, other technical disciplines, or equivalent. Training in Quality Systems, including Quality Systems Regulations (QSRs) and Good Manufacturing Practices (GMPs) for medical devices and International Organization for Standard...
Sr Specialist, Professional Affairs and Clinical Education
Responsible for supporting and leading the management of Professional Affairs and Clinical Education initiatives and programs to maintain and expand the worldwide adoption of MicroVention products. ...