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Regulatory Affairs Associate

Company: Experis
Location: Santa Clara
Posted on: November 22, 2022

Job Description:

Experis, a ManpowerGroup company, has an exciting contract opportunity with one of our key clients, a global medical devices and health care company that is engaged in the discovery, development, and manufacturer of medical equipment and healthcare products. Job Title: Regulatory Affairs AssociateLocation: Santa Clara, CADuration: 12 months (with possible extension)Shift: Day- 08:00 AM to 05:00 PMPosition Summary:This role will provide support to the Regulatory Affairs organization by -

  • Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system
  • Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidance's are met
  • Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission
  • Driving quality system process improvement initiatives. Initiatives include but are not limited to:
  • Establishing emerging issues in our quality system
  • Maintaining the quality system procedures (e.g. change management)
  • Liaising with cross-functional partners, distribution centers, and international affiliates to obtain/align on international regulatory requirements
  • Troubleshooting with regulatory affiliates
  • Participating in RA projects. Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations. Exposure to Quality Systems, a Quality role, or a Compliance role is a plus. Additional Comments:
  • Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
  • Review/approval of engineering study protocols/reports and validation study protocols/reports.
  • Review and approval of manufacturing changes for Class III implantable medical devices.
  • May require an advanced degree and 5-8 years of direct experience in the field.
  • 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.
  • Relies on extensive experience and judgment to plan and accomplish goals.
  • Performs a variety of tasks. May lead and direct the work of others.
  • A wide degree of creativity and latitude is expected.
  • Typically reports to a manager or head of a unit/department.APPLY TODAY!

Keywords: Experis, Santa Clara , Regulatory Affairs Associate, Other , Santa Clara, California

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