Regulatory Affairs Project Manager

Company: MicroVention-Terumo
Location: Aliso Viejo
Posted on: January 16, 2023

Job Description:

MicroVention - Terumo
About MicroVention and Why We're HiringVoted Great Places to Work - 2022, we'rea medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We're a high growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what MicroVention - TERUMO has to offer.
Let's Talk About Life at MicroVention & Who You'd Be Working WithWe believe a diversity of backgrounds, beliefs, abilities, and experiences is critical to our success. We are committed to attracting, recruiting, and retaining the best talent, focusing on diversity, inclusion, and belonging while bringing forth new technologies to advance the neuroendovascular industry. Our team is collaborative, customer-focused, and thrives on innovation. MicroVention offers challenges, rewards, and the opportunity to work with talented colleagues in an exciting, innovative, and safe environment.
Project Manager, Regulatory AffairsThe Project Manager, Regulatory Affairs is responsible for obtaining regulatory approvals, and ensures compliance to FDA and international regulatory agency requirements including ISO, local, state and/or federal requirements.
What You'll Be Doing

• Serve as a member on project teams.
• Identify regulatory requirements in each country.
• Develop worldwide regulatory strategies.
• Prepare, review and file worldwide regulatory submissions and dossiers to ensure MicroVention devices are commercially available in the U.S. and international markets based on the organization's objectives.
• Communicate with regulatory agencies on administrative and routine matters.
• Document, consolidate and maintain oral and written communication with the regulatory agencies.
• Develop and maintain regulatory files and records.
• Review change order documents and ascertain impact on current regulatory approvals.
  The Skills/Experience Needed for the Role
  • B.S./B.A. degree in Science, Engineering or Medical Technology (or equivalent related experience).
  • Minimum of seven (7) years of medical device industry experience.
  • At least five (5) years of Regulatory Affairs experience.
  • Extensive experience in preparation of U.S. and international regulatory submissions including 510(k), Humanitarian Device Exemption (HDE), Investigational Device Exemption (IDE), Pre-Market Approval (PMA) and Design Dossier applications (implant and catheter experience preferred).
    How to Differentiate Yourself from the Crowd
    • Excellent leadership skills.
    • Ability to work well in a team environment.
    • Detail oriented
    • Proven analytical abilities and organization skills.
    • Ability to comprehend technical documents and concepts.
    • Proficient computer skills (e.g., MS Office).
      Take Vacation (Seriously)Yes, we really want you to take vacation. In fact, we have 15 days of PTO and 12-13 Paid Holidays per year. It's important to get plenty of rest and get out and do something. As part of our paid holidays, in December, we close our offices the entire week.
      Our PerksMedical, Dental, Vision, and 401(k) with Company Match, Casual Work Environment, Work/Life Balance, Talent Development Program, On-site Gym/Exercise Room, Employee Referral Program, Tuition Reimbursement up to $6,400/Year, LinkedIn Learning Courses, and the list goes on.
      P.S. If this position isn't right for you at this time, but you know someone else who might be interested, we'd really appreciate it if you passed this along.
      We're not just a place to work, but a company to build your career!
      We are an equal opportunity employer (EOE) and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status,or any other characteristic protected by law.

Keywords: MicroVention-Terumo, Aliso Viejo , Regulatory Affairs Project Manager, Executive , Aliso Viejo, California