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Senior Specialist, Regulatory Affairs - Transcatheter Heart Valve

Company Name: Edwards Lifesciences LLC
Location: Irvine, CA
Job Type: Regulatory Affairs
Contact Name: Patricia Forrest
Phone:
Fax:
Email: apply directly online
Salary:

Job Description

Outstanding opportunity to be a part of Edwards’ Transcatheter Heart Valve program, representing one of the medical device industry’s most groundbreaking technological innovations. Edwards has a strong pipeline in this space and the regulatory pathway is critical to getting these lifesaving products to our clinicians and patients. We are looking for Sr. Regulatory Affairs Specialist, an individual with 5 years of experience in Medical Device, preferably in Class III devices and with exposure to PMA products.

  • Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues; also keeps management apprised of alternative actions
  • Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions. (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files)
  • Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process
  • Review product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy

 

Job Requirements (up to 200 words): 

Qualifications/Education: 

  • A Minimum of 5 years’ experience within medical device regulatory affairs
  • A Bachelor’s degree is required. A science degree is strongly preferred
  • Proven expertise in Microsoft Office Suite Including Word, PowerPoint and Excel
  • Excellent written and verbal communication skills including negotiating and relationship management skills
  • Excellent problem-solving, organizational, analytical and critical thinking skills
  • Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III
  • devices
  • Full knowledge and understanding of global regulatory requirements for new products or product changes
  • Full knowledge of new product development systems
  • Good leadership skills and ability to influence change
  •  Strict attention to detail
  • Ability to manage competing priorities in a fast paced environment
  • Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects. 

 

Please apply online at:

https://edwards.taleo.net/careersection/jobdetail.ftl?job=011191&lang=en