MicroVention is now Terumo Neuro

Sr. Specialist, Regulatory Affairs

Position Overview

Responsible for preparing strategy for worldwide product approval 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 global 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.

Job Details

Job ID 12814BR

Aliso Viejo, California, USA

Salary Range:

$91,628 - $120,263 (Financial compensation packages may be higher/lower than listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand)

Apply for this job
    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 attention to detail.
    6. Strong written and verbal communication skills.
    7. 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. Strong technical writing skills.
    5. Proven analytical abilities and organization skills.
    6. Ability to comprehend technical documents and concepts.
    EEO
    We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law.

    Fair Chance Ordinance
    If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

    Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.