Regulatory Recall Specialist

JSG (Johnson Service Group, Inc.); California; À distance; USD 70 000 - 90 000; Plein temps

Avantages offerts par ce poste

Medical insurance

Dental insurance

Vision insurance

401(k)

Weekly pay

Résumé du poste

A leading staffing firm is seeking a Regulatory Product Safety & Vigilance Specialist for a remote position in California. This role involves assessing product safety risks, managing complaints, and ensuring compliance with regulatory requirements in the medical device industry. A successful candidate will have 3–5 years of experience in a regulated environment, preferably within medical devices or pharmaceuticals, along with strong documentation and analytical skills. Our company offers competitive benefits including medical coverage and a 401(k).

Qualifications

• 3–5 years of experience in a regulated environment, preferably in medical devices or pharmaceuticals.
• Experience in Product Safety, Vigilance, or Quality.
• Strong documentation and analytical skills.

Responsabilités

• Assess and investigate product complaints and reportable events.
• Perform product surveillance and trend analysis to identify safety risks.
• Support regulatory reporting and coordinate investigations.

Connaissances

3–5 years of experience in a regulated environment

Product Safety or Vigilance experience

Strong documentation skills

Analytical skills

Communication skills

Proficient with MS Office

Formation

Bachelor’s degree or equivalent experience

Outils

SAP

Description du poste

Johnson Service Group, a nationally award-winning staffing firm, has an immediate opportunity for a Regulatory Product Safety & Vigilance Specialist with a global medical device client.

1 Year Contract | Remote in CA |

Summary

The Product Safety & Vigilance Specialist is responsible for identifying, assessing, and managing real or potential product safety risks to ensure compliance with global regulatory requirements and internal procedures. This role serves as a subject matter expert in medical device reporting and complaint management, partnering cross-functionally to support patient safety, regulatory compliance, and continuous product improvement.

Key Responsibilities

• Assess and investigate product complaints and potentially reportable events
• Perform product surveillance and trend analysis to identify safety risks
• Determine reportability, conduct risk assessments, and support regulatory reporting
• Coordinate investigations including failure analysis, nonconformance, and CAPA
• Collaborate with Engineering, Manufacturing, Quality, and Regulatory teams
• Ensure complete, accurate, and timely documentation through case closure
• Support Field Safety Corrective Actions and regulatory audits (FDA, ISO, etc.)

Qualifications

• 3–5 years of experience in a regulated environment (medical device or pharma preferred)
• Experience in Product Safety, Vigilance, Quality, or Product Surveillance
• Strong documentation, analytical, and communication skills
• Proficient with MS Office; SAP experience preferred
• Bachelor’s degree or equivalent experience

JSG offers medical, dental, vision, life insurance options, short-term disability, 401(k), weekly pay, and more. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law