Regulatory Documentation Specialist

Experis Technology Group; United States; Remote; USD 34,000 - 41,000; Full time

Benefits offered by this job

Remote work flexibility

Project-based role

One-year duration with renewal

Job summary

ManpowerGroup Global, Inc. seeks a SAF Regulatory/Environmental Analyst to support product safety and regulatory compliance initiatives within the Regulatory Affairs team.

The role emphasizes documentation remediation, data tracking, and cross-system coordination. The position is remote (CST) with a roughly one-year project duration and potential renewal; requires a Bachelor's degree in a scientific/engineering or regulatory field, strong analytical skills, and proficiency with Excel and 365

Qualifications

• Bachelor's degree in a scientific, engineering, regulatory affairs, quality, or related discipline.
• Experience managing technical documentation, compliance records, or databases.
• Strong analytical skills with the ability to perform detailed gap analysis and organize large datasets.
• Excellent written and verbal communication skills to clearly convey findings and recommendations.
• Proficiency with Microsoft Excel and other Microsoft 365 applications.

Responsibilities

• Support the management and remediation of product safety documentation, including Biological Evaluation Reports (BERs) and Lifecycle Management (LCM) records.
• Assess current documentation for compliance, accuracy, and completeness, identifying gaps and technical debt.
• Coordinate updates and standardization of safety and compliance records across multiple systems such as PLM, SAP, and CDMS.
• Develop and maintain tracking tools, dashboards, and databases to monitor documentation status and remediation progress.
• Assist with rebranding activities and data cleanup efforts to ensure regulatory readiness and operational efficiency.

Skills

Data analysis

Documentation management

Excel

Communication

Regulatory knowledge

Education

Bachelor's degree in a scientific/engineering/regulatory field

Tools

PLM

SAP

CDMS

Job description

Our client, a leader in the healthcare and medical device industry, is seeking a SAF Regulatory/Environmental Analyst to join their team. As a SAF Regulatory/Environmental Analyst, you will be part of the Regulatory Affairs department supporting product safety and compliance initiatives. The ideal candidate will demonstrate strong organizational skills, attention to detail, and proactive communication, which will align successfully in the organization.

Job Title:Product Stewardship Data & Documentation Remediation Specialist Location: This position is fully remote in CST

Pay Range: $25-30/hr on W2

What's the Job?

• Support the management and remediation of product safety documentation, including Biological Evaluation Reports (BERs) and Lifecycle Management (LCM) records.
• Assess current documentation for compliance, accuracy, and completeness, identifying gaps and technical debt.
• Coordinate updates and standardization of safety and compliance records across multiple systems such as PLM, SAP, and CDMS.
• Develop and maintain tracking tools, dashboards, and databases to monitor documentation status and remediation progress.
• Assist with rebranding activities and data cleanup efforts to ensure regulatory readiness and operational efficiency.

What's Needed?

• Bachelor's degree in a scientific, engineering, regulatory affairs, quality, or related discipline.
• Experience managing technical documentation, compliance records, or databases.
• Strong analytical skills with the ability to perform detailed gap analysis and organize large datasets.
• Excellent written and verbal communication skills to clearly convey findings and recommendations.
• Proficiency with Microsoft Excel and other Microsoft 365 applications.

What's in it for me?

• Opportunity to contribute to impactful projects that enhance product safety and regulatory compliance.
• Flexible remote work environment supporting work-life balance.
• Engagement in a dynamic team focused on continuous improvement and innovation.
• Potential for professional growth within a reputable organization.
• Participation in a project-based role with a duration of approximately one year, with possible reassessment based on project needs.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay