Regulatory Affairs Associate
Location: Santa Clara
Posted on: November 22, 2022
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
- Liaising with cross-functional partners, distribution centers,
and international affiliates to obtain/align on international
- 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
- Performs a variety of tasks. May lead and direct the work of
- A wide degree of creativity and latitude is expected.
- Typically reports to a manager or head of a
Keywords: Experis, Santa Clara , Regulatory Affairs Associate, Other , Santa Clara, California
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