Senior Specialist, Regulatory Affairs - Transcatheter Mitral and Tricuspid Therapies
Company: Edwards Lifesciences Corp
Posted on: June 7, 2021
The Senior Regulatory Affairs Specialist will focus on
supporting US and EU submissions. This opportunity presents a
unique opportunity to lead the way in the Transcatheter Mitral and
Tricuspid Therapies and cutting-edge technology.
- Represent regulatory affairs on product development and
commercialization teams related to TMTT.
- Provide guidance on regulatory requirements necessary for
strategic and contingency planning, including developing regulatory
strategic plans to teams for solutions.
- Prepare and oversee documentation packages for submission to
global regulatory agencies. Track timelines and documents milestone
achievements for inclusion in regulatory submissions. May interact
with regulatory agencies as part of submission review and on-site
audit support. (e.g., IDE's, PMA's, annual reports, 510(k)'s,
STED's and CE marking design dossiers and technical files).
- Will monitor proposed and current US and EU regulations and
guidance, and will advise the impact of such regulations and
guidance on the company within the scope of assigned.
- Responsible for regulatory review for claims support of
promotional material, labeling content, product and process
changes, and product documentation.
- Able to collaborate and take direction from team leaders, while
working with RA management as required.
- Additional Regulatory Affairs related projects as
- A Bachelor's degree is required. A science degree is strongly
A minimum of five years of related experience is required with a
bachelor's degree, OR, a minimum of three years of related
experience is required with a master's degree
Class II and Class III regulatory affairs experience within the
medical device industry is preferred.
- Must possess a strong working knowledge of US /EU regulations
that affect Class III devices. Experience preparing domestic and
international product submissions is preferred.
- Must have strong English written and verbal communication
skills, and have experience working on cross-functional
- Strong ability to problem-solve and apply analytical thinking
Edwards is an Equal Opportunity/Affirmative Action employer
including protected Veterans and individuals with disabilities.
Keywords: Edwards Lifesciences Corp, Irvine , Senior Specialist, Regulatory Affairs - Transcatheter Mitral and Tricuspid Therapies, Other , Irvine, California
Didn't find what you're looking for? Search again!