IrvineRecruiter Since 2001
the smart solution for Irvine jobs

Edwards Lifesciences: Senior Specialist, Regulatory Affairs - Critical Care

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

Job Description:

This is an outstanding opportunity to be a part of a forward-thinking regulatory affairs organization. The Senior Specialist, Regulatory Affairs will focus on supporting projects for our critical care products. We are looking for a diligent Sr. RA professional who works well across functional teams, takes initiative, and enjoys working in a fast-paced team environment.Job Description:Represent regulatory affairs on product development, commercialization, and sustaining teams related to Critical Care Products.Interacts with FDA and other regulatory bodies under management guidance for submissions and projects.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 assignedMay provide 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 on resolution of RA issues and strategy.Qualifications/Required Skills/Experience and Education:A minimum of five years of experience within medical device regulatory affairs is required with a Bachelor's degree, OR a minimum of three years of experience is required with a Master's degree.A Bachelor’s degree is required. A science/engineering degree is strongly preferred.Must possess a strong working knowledge of US /EU regulations that affect Class II and/or Class III devices. Experience with US Class II devices and 510(k) submissions is required, Class III experience is a plus.Experience in preparing US and EU product submissions are required. Knowledge of EU MDR is preferred. Knowledge of Canada, Australia, and New Zealand submissions preferred.Must be competent in applying the appropriate regulatory requirements for new products or product changes as it relates to the regulatory impact of class II and III devices. – Requires familiarity with new product development systems.Must have strong written and verbal communication skills, and have experience working on cross functional project teams.Strong ability to problem solve and apply analytical thinking is required.Experience with hemodynamic monitoring devices, software in a medical device, software as a medical device, mobile applications, algorithms, preferred.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


High Demand For Quality Contractors - Get New Clients In Your Area
Description: Over 25 million homeowners have trusted HomeAdvisor 1800Contractor to help them find quality professionals with the expertise to turn their home improvement
Company: HomeAdvisor
Location: San Gabriel
Posted on: 10/20/2020

Pediatric Dentist- Guaranteed Comp,up to $25K for Relo & Sign on
Description: JOB TITLE: Pediatric Dentist REPORTS TO: Regional Dental Director FLSA: Exempt Welcome to Preventistry We are revolutionizing oral health for everyone by redefining prevention and care. A more (more...)
Company: Advantage Dental
Location: Santee
Posted on: 10/20/2020

Leasing Consultant
Description: InterSolutions is searching for a sales-oriented and enthusiastic individual to fill a Leasing position with one of our top clients in Santee, CA We offer our associates Edge2Learn training, career (more...)
Company: InterSolutions
Location: Santee
Posted on: 10/20/2020


Warehouse Associate - Make $22.75 per hour!
Description: Position Description br Starting Base Pay: 16.75 br Walmart is rolling out amazing peak season pay increases for all associates from 9/26/20 to 1/1/21 br All LAX1 associates receive an additional (more...)
Company: Walmart
Location: Rowland Heights
Posted on: 10/20/2020

Weekend Warehouse Production Associate
Description: Looking for a 2nd job Need a weekend schedule Then we have the job for you Our client is hiring for positions to start immediately Pay rates starting at 19.00- 19.50 per hour Adecco is assisting (more...)
Company: Adecco
Location: Rowland Heights
Posted on: 10/20/2020

Tax Professional - CPA - Remote
Description: Overview If you are a highly motivated individual with an active unrestricted credential CPA/EA/Practicing Attorney and excellent communication skills, we need you to help our customers complete their (more...)
Company: Intuit
Location: Santee
Posted on: 10/20/2020

Operations Supervisor - Warehouse (Supply Chain/Logistics)
Description: Description: Penske Logistics is seeking a proven leader with relevant experience and skills to join our team of logistics professionals. We are seeking a candidate to provide leadership at one of our (more...)
Company: Penske Truck Leasing
Location: Rosemead
Posted on: 10/20/2020

Students - Deliver with Uber Eats
Description: Students - Deliver with Uber Eats Santee, CA 2854 C2-111588 Deliver with Uber. Earn on your schedule. Deliver with Uber Eats on your schedule. Deliver for a few hours in the mornings, every night, or (more...)
Company: Uber Eats
Location: Santee
Posted on: 10/20/2020

Licensed Medicare Insurance Sales - Remote
Description: If you've sold Medicare, Life, or Auto Insurance before, you'll want to consider this unique sales opportunity. Join the revolutionary ASSURANCE platform and uncap your earnings on the industry--s best (more...)
Company: ASSURANCE Independent Agents
Location: Santee
Posted on: 10/20/2020

Property Field Adjuster- San Diego, CA
Description: Purpose of Job Company Vehicle Provided br Looking for experienced Property Field adjusters in the San Diego, CA Metro br br Within defined guidelines and framework, provides PROPERTY claims (more...)
Company: USAA
Location: Santee
Posted on: 10/20/2020

Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Irvine RSS job feeds