Advertising Compliance Specialist ensuring compliance and operational excellence in the insurance sector. Collaborating on regulatory changes and supporting product development in a hybrid role.
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
Intern coordinating regulatory projects and compliance for Eversource Energy, engaging with legal, regulatory, and business teams. Involves monitoring regulatory changes and ensuring compliance across your duties.
Regulatory Policy Specialist developing regulatory case filings and strategies supporting company goals at Xcel Energy. Collaborating with stakeholders and senior management to ensure compliance and effective communication.
Manager overseeing leave and immigration compliance at Cedars - Sinai Medical Center. Ensuring adherence to laws while leading HR and compliance teams.
Experienced Quality Systems Specialist at Boeing supporting FAA Certification activities. Involves quality assurance plans and audits in manufacturing and regulatory environments.
Chief of Regulation overseeing programmatic and operational activities for Florida's Division of Licensing. Responsible for budget management and ensuring compliance with policies and procedures.
Compliance Business Oversight Manager managing compliance risk at TD Bank. Overseeing Affiliate Transactions Data Review and providing insights on regulatory compliance.
Regulatory Affairs Professional creating clinical evaluation documents for medical devices in a fast - growing biotech company. Collaborating with stakeholders and ensuring compliance with regulations.
Manager overseeing regulatory affairs for a German implant company in facial and trauma products. Ensuring compliance with regulations, preparing submissions, and advising on medical affairs.
Compliance Manager reviewing broker - dealer and registered investment adviser communications for regulatory compliance. Working collaboratively with diverse business partners in a hybrid work environment.