Regulatory Specialist

Regulatory Specialist (Manufacturing/Biotech)

Irvine, CA ( local candidates)

$48-52hr ( Weekly pay + benefits)

Contract: 7 month ( Excellent potential for extension or permanent)

Full-time: Hybrid 8am-5pm ( Days onsite to be determined)

Our client is a global team of innovators, leaders, creators, builders, and problem solvers. They develop state-of-the-art instruments and reagents for life science research laboratories and healthcare facilities all over the world. Together they are helping people everywhere live longer, healthier lives As part of the global PSUR Reporting Team, the candidate will be facilitating business data collection and reporting efforts and generating periodic product PSUR / post market surveillance reports. This includes regular interactions with area subject matter experts to ensure data is collected, documented, and analyzed in a timely and accurate manner. The candidate will use local and global systems to collect various post market information such as complaint, field corrective action and CAPA data. In addition, the QE will work with subject matter experts to analyze product related data and document conclusions of the review activities.

How You'll Make An Impact:

• Facilitation and generation of product Post Market Surveillance (PMS) and PSUR reports including:
• Analysis of post market data and reviewing completed reports with business partners.
• Maintaining and supporting databases and systems used for tracking various quality management system (QMS) activities related to post market surveillance.
• Maintain, archive and completed controlled quality records.
• Coordinate PMS and post market performance follow-up (PMPF) deliverables with internal business partners.
• Facilitate and/or chair local/regional PMS Board meetings.
• Support various QMS and PMS projects (local and global) as needed.
• Support internal/external audits as needed.
• Perform other related duties and assignments as needed.

You Bring:

• Bachelor’s degree or equivalent in a related life science/technical/engineering discipline or equivalent preferred.
• 5+ years experience in a Regulated Manufacturing industry.
• Working knowledge of device/drug/biotech manufacturing processes.
• Understanding of GMP(Good Manufacturing Practice) and quality system standards as they apply to products manufactured by company
• Bonus: Understanding of product post market surveillance requirements for IVD products
• Bonus: Experience with electronic QMS systems (i.e. Veeva, EtQ, Trackwise)
• Advanced technical writing and word processing skills.
• Detail-oriented and ability to multitask.
• Problem solving, decision making, time management, organization, communication, leadership, and computer skills.