Sr. Specialist, Regulatory Affairs

at  MicroVention Inc

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.

• 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