Specialist, International Regulatory Affairs - Critical Care

Company: Edwards Lifesciences Corp
Location: Irvine
Posted on: November 22, 2021

Job Description:

The Specialist, International Regulatory Affairs, completes and maintains regulatory approvals and clearances of assigned products.

Key Responsibilities:

• Author and oversee documentation packages for submission to global regulatory agencies (eg: Japan, China, EEMEA, ASEAN, Latin America).
• Track timelines and document milestone achievements for inclusion in international regulatory submissions.
• Participate in obtaining guidance and feedback from in-country regulatory teams on registration requirements for new and renewal registrations, product and process changes to meet regional-requirements and proposing suggestions for expediting approvals.
• Participate in obtaining guidance and feedback on proposed and current international regulations. Advise the impact of such regulations to Business Unit RA team.
• Collaborate with cross-functional teams and take direction from Regulatory Affairs team leaders.
• Support and strengthen the communication processes between International RA and the Business Unit RA Team
  Basic & Preferred Qualification
  
  • Bachelor's degree plus a minimum of three years of relative experience required (OR Masters Degree plus minimum of one year relative experience)
  • Bachelor's degree in a related scientific discipline is preferred.
  • Class II and Class III international regulatory affairs experience within the medical device industry is preferred.
  • Must possess a some knowledge of international regulations. Experience preparing international product submissions is preferred.
  • Must have strong English written and verbal communication skills, and have experience working on cross functional project teams.
  • A strong ability to problem solve and apply analytical thinking is required.
    
    E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
    
    Edwards is committed to complying with the requirements and guidance from our government authorities and to protecting our vulnerable patients and the healthcare providers who are treating them around the world. As such, all patient-facing and in-hospitals positions require COVID-19 vaccination, which includes anyone who directly interfaces with patients and those who enter a hospital or healthcare facility as part of their role. If hired and your position meets this criteria , as a condition of employment, you will be required to submit proof that you have been fully vaccinated for COVID-19 or have a valid religious or medical exemption from being vaccinated.

Keywords: Edwards Lifesciences Corp, Irvine , Specialist, International Regulatory Affairs - Critical Care, Other , Irvine, California