Apex Systems

Regulatory/Quality Engineer
  • Job Type: Full Time
  • Industry Type: IT Sector
  • Industry Location: Sylmar
  • Experience: NA
  • No. of Positions: 1
  • Primary Skills: Quality Engineer Consult Management Research Development Engineering
  • Secondary Skills: Performance Analysis FDA Systems Scripts
  • Job Location: Sylmar, California
  • Posted Date: Posted today
Job Description

Regulatory/Quality Engineer

Sylmar, CA

  • LifeScan experience is not required Consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations and Product Performance Analysis teams to manage the requirements and timelines to assure the appropriate Regulatory activities are performed for assigned projects.
  • Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports) as well as support/perform the necessary submissions for EU and other world-wide geographies as applicable.
  • Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of manufacturing changes for Class III implantable medical devices
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • Performs a variety of tasks. May lead and direct the work of others.



Qualifications:

  • 4 year Degree
  • 5-7 years experience with Regulatory Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval - Primarily US and EU.
  • Recent experience with Class III implantable medical devices
  • Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements
  • Knowledge of FDA PMA guidance documents and CFR regulations
  • A wide degree of creativity and latitude is expected.



EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or

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