Sr. Specialist, Regulatory Affairs

1 month ago

Aliso Viejo, United States MicroVention Full time
Job Description

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.


Qualifications

  1. Bachelor's degree in a scientific or technical discipline or relevant field of study.
  2. Minimum four (4) years of relevant professional regulatory experience.
  3. Strong technical writing skills as evidenced by successful U.S. FDA Class II / III medical device submissions, EU CE Mark applications, Health Canada submissions, and/or the rest of the world (ROW) registrations.
  4. Experience interfacing with regulatory authorities through various stages of device life cycle.
  5. Strong written and verbal communication skills.
  6. Proficient computer skills, including MS Word, Excel, Outlook, and Teams.
Desired Qualifications
  1. Advanced degree in a scientific or technical discipline or relevant field of study.
  2. Experience in leading small to medium sized teams.
  3. Ability to work well in a team environment.
  4. Detail-oriented.
  5. Strong technical writing skills.
  6. Proven analytical abilities and organization skills.
  7. Ability to comprehend technical documents and concepts.

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