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Regulatory Affairs Specialist

Contract: Austin, Texas, US

Salary Range: 30.00 - 34.00 | Per Hour

Job Code: 357131

End Date: 2025-01-26
Days Left: 16 days, 2 hours left

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Job Description:

Job Summary:

We are seeking a meticulous and detail-oriented Quality Documentation Specialist to support operations in a regulated medical device manufacturing environment. The ideal candidate will have experience in handling device history records, batch reviews, and quality documentation to ensure compliance with strict industry standards. This role demands a strong ability to follow procedures, review documents for accuracy and completeness, and escalate issues when necessary. This position will support 3rd party for medical devices, device history records and mostly will handle Batch Records.

Key Responsibilities:

• Perform detailed reviews of batch records and other quality documentation.
• Ensure all documentation aligns with established procedures and regulatory requirements.
• Approve or reject quality documents based on defined criteria and escalate discrepancies.
• Support the release process for batches, ensuring all documentation is accurate and complete.
• Collaborate with cross-functional teams to resolve documentation issues promptly.
• Handle non-conformance reports and assist with CAPA (Corrective and Preventive Actions) as required.
• Maintain strict adherence to procedures, quality standards, and compliance regulations.

Qualifications:

• Education: Bachelor's degree in a STEM-related field (Engineering or Science disciplines preferred).
• Experience: Minimum of 3 years in a regulated medical device or pharmaceutical manufacturing environment (internships, co-ops, or academic projects do not qualify).
• Proven experience with:
• Batch record review and approval processes.
• Quality document review in manufacturing, design, or release contexts.
• Handling non-conformances and CAPA processes (preferred).
• Skills:
• Strong attention to detail and accuracy in documentation.
• Ability to meticulously follow established procedures.
• Understanding of medical device quality documentation requirements.
• Excellent organizational and problem-solving skills.
• Other Requirements:
• Must work onsite in Austin, TX during designated hours.

Top Skills for Success:

1. Ability to follow and enforce procedures.
2. Strong attention to detail.
3. Comprehensive understanding of medical device quality documentation standards.

Pay Range: $30/hr. - $34/hr.

Job Requirement

• Medical Devices/Pharmaceuticals
• Batch Records
• Documentation
• CAPA
• Regulatory Affairs

Reach Out to a Recruiter

• Recruiter
• Email
• Phone
• Vishnu Nair
• vishnu.nair@collabera.com

Apply Now Collabera

Job Tags

Hourly pay, Contract work,

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