Specialist, International Regulatory Affairs - Critical Care
Company: Edwards Lifesciences Corp
Posted on: November 22, 2021
The Specialist, International Regulatory Affairs, completes and
maintains regulatory approvals and clearances of assigned
- Author and oversee documentation packages for submission to
global regulatory agencies (eg: Japan, China, EEMEA, ASEAN, Latin
- 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
- 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
- Bachelor's degree in a related scientific discipline is
- 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
- Must have strong English written and verbal communication
skills, and have experience working on cross functional project
- A strong ability to problem solve and apply analytical thinking
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
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