QA/RA Associate - Onsite
Collabera Inc.
Quality Assurance
Santa Clara, CA, USA
USD 38-45 / hour
Posted on Apr 2, 2025
QA/RA Associate - Onsite
Contract: Santa Clara, California, US
Salary Range: 38.00 - 45.00 | Per Hour
Job Code: 360514
End Date: 2025-05-01
Days Left: 28 days, 7 hours left
Position Details:
Industry: Medical Devices
Job Title: QA/RA Associate - Onsite
Location: Santa Clara, CA 95054
Duration: 12+ months contract [+ Possibilities of extension]
Pay Range: $38-$45/hr
Job Description: This is a good opportunity for a QA person to move to regulatory operations.
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 guidances are met,
- Fulfilling international submission deliverables for product registration renewals and for regulatory emerging issues where multiple medical devices require submission, including maintaining tracker of Declarations of Conformity, confirming against local requirements, and driving to issuance.
- 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, and
- Participating in RA projects.
- Role has a potential for investigating nonconformances (CAPAs) and implementing mitigations.
List of tasks:
- CFG requests in the FDA database.
- Declarations of conformity.
- Review Regulatory Letters and maintain LoA / PoA tracker.
- Will coordinate pan-franchise requests for multiple products, schedule meetings with international requesters.
- Maintain tracker / SharePoint / folders with current state.
- Change management
Skills:
- Exposure to Quality Systems, a Quality role, or a Compliance role is a plus.
- Change Control, Change Management, Quality experience
- Independent
- Troubleshooting
- Critical thinker
- Ability to drive a problem through resolution and implement mitigations.
- Ability to handle multiple streams simultaneously.
Job Requirement
- QA
- QA/RA
- Quality Assurance
- Change Control
- Change Management
- Change order
- CAPA
- Non-conformance
- FDA submissions
- Product registration
- Regulatory Affairs
- Medical Device
- Medical Devices
- ISO 13485
- ISO 14971
- Quality systems
- QMS
- Quality Management
Reach Out to a Recruiter
- Recruiter
- Phone
- Niharika Shrivastava
- niharika.shrivastava@collabera.com