Compliance Intern offering forensic analysis support for Johnson & Johnson. Engaging in audits and analytical tasks in a hybrid work environment in New Brunswick, NJ.
About the role
- Supports the Quality & Regulatory department at Indica Labs in maintaining compliant quality systems for medical devices. Collaborates with cross-functional teams to ensure regulatory compliance
Responsibilities
- Supports quality operations & documentation control ensuring alignment with company procedures and global regulatory requirements
- Maintains controlled documents and records throughout their lifecycle
- Contributes to the development and revision of controlled documents, quality records, and design documentation in collaboration with cross-functional teams
- Executes and supports QMS processes including non-conformance, CAPA, change control, and complaint handling activities
- Assists with investigation documentation, tracking, trending, and closure to support continuous improvement and regulatory compliance
- Assists in maintaining vendor qualifications and supplier agreements
- Provides regulatory support in the preparation, review and maintenance of regulatory submissions, dossiers, and technical files for global filings
- Assists with audit preparations and inspection readiness activities and serves as support during external audits
- Works closely with Product Development, Engineering, and Operations teams to support compliance and quality objectives
- Supports project timelines for quality and regulatory deliverables
- Assists in developing product documentation and participates in verification that products consistently meet specification, safety, identity, and performance requirements
Requirements
- Bachelor’s Degree in Life Sciences, Engineering, Regulatory Affairs, Quality, or related discipline
- Two (2) years of related experience in Quality Assurance or Regulatory Affairs in a medical device or IVD environment
- Working knowledge of related industry regulations and standards
- Experience with quality management systems and document control processes.
- Authorization to work in the United States, or appropriate authorization to work in the applicant’s current home country (Indica Labs does not sponsor work visas)
Benefits
- Health insurance
- 401(k) matching
- Paid time off
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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