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Senior Program Manager Regulatory Affairs - Critical Care

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Full-Time
Contact Name: Patricia Forrest
Phone:
Fax:
Email: apply directly online (see below)
Salary:

Job Description

As a Sr. Program Manager, Regulatory Affairs Critical Care you will play a key role in expanding our regulatory support across the critical care business. You will be responsible for maintaining and documenting our mission critical domestic and international regulatory filings and registrations all the way from preparing submissions, including IDEs, 510(k)s, PMAs and design dossiers and technical files for CE marking, to obtain and maintain approvals for commercially distributing products worldwide to representing Regulatory Affairs on new product development and manufacturing support teams, as needed. You will also exercise judgment in determining appropriate regulatory action and requirements for new product or product changes and preparation of regulatory documents and may interact directly with regulatory agencies under management guidance.



Job Requirements 

- A minimum of 12 years of applicable experience is required

- Bachelor's degree in nursing, science or engineering is required; an science advanced degree is preferred.

- Demonstrates a sense of urgency; understands the importance of outperforming and outpacing the competition in meeting customer’s and patient’s needs.

- Good conceptual, analytical, problem solving, and organizational skills.

- A “hands-on” individual, who enjoys challenge, is capable and dedicated to getting the job done with minimal support and direction in alignment with business needs.

- An assertive, take-charge, proven regulatory professional with a strong results orientation, positive “can do” attitude, and a sense of urgency to get things done.

- Ability to travel up to 30%. 

 

Please apply online at: https://edwards.taleo.net/careersection/jobdetail.ftl?job=012968&lang=en