SignalPath is a fun, engaging, and growing organization that is focused on delivering high-quality technology solutions for our clients. The Compliance Analyst II role requires a flexible and versatile contributor responsible for ensuring compliance for accuracy and data integrity, with federal and state regulations and controls for software development lifecycle processes and systems. This role will provide quality support for but not limited to, document control and management processes, and compliance training protocols as a subject matter expert. We are seeking a detail-oriented, analytically proficient, strong communicator operating in integrity with the ability to perform under pressure to think critically and problem solve in a fast-paced and dynamically growing environment.
- Evaluate conformance to compliance regulations and legal and contractual obligations to the internal operational and procedural compliance.
- Communicate compliance policies and guidelines to the management and departments.
- Provide guidance to departments in the development and execution of new compliance policies and procedures as required.
- Develop and maintain compliance accuracy and consistency with the recordkeeping system.
- Analyze existing compliance policies and related documentation to maintain a standard business continuity process improvement.
- Applies regulations to the current or new procedural documents and serves as a document approver.
- Provide transparency and information to employees on compliance training requirements.
- Incorporate regulation requirements and amendments to processes as needed to maintain conformance in the organization.
- Team-player, customer-centric attitude that can effectively work both independently and within a team.
- Bachelor’s degree in healthcare, compliance, ethics & regulations, engineering, technology, law, or management required. (Other relevant degrees, certifications, and/or experience may be considered as equivalent as described herein.)
- 4+ years of FDA-regulated industry work experience.
- 3+ years of experience in compliance, document management, or project management role.
- Exemplify analytical and reading skills required to gather, interpret, and compile data into formalized reports for industry general technical procedures and documents, and government regulations.
- Demonstrate excellent oral and written communication skills, with proven computer proficiency with (MS Office products as Excel, PowerPoint, Google Suite, QMS systems, Project Management Systems, and exposure to cloud technology).
- Exceptional organizational & attention to detail and follow-up skills required to manage key (i.e., confidential) projects and multi-task document review priorities to allocate resources in line with priorities with a focus on both timeliness and accuracy of services. Deadline driven.
- Contributes to compliance team effort and initiatives for measures required to cultivate a compliance experience in the organization with project management leadership experience.
- Reviewing and monitoring governmental regulations and standard notifications and other sources of information that apply to the organization.
- Collaborate with teams to ensure conformance with regulatory controls to ensure guidelines that apply are followed in the organization.
- Working knowledge of regulations controls, including 21 CFR Part 11, FDA guidelines, SOC 2, ISO 27001, GDPR, ICH-GCP, HIPAA, PHI, Annex 11 affecting manufacturing companies and other regulatory agencies.
- Competitive health, dental, life and disability insurance plans
- Company 401k match
- Great location in downtown Raleigh
- Flexible work schedule
- Generous PTO Plan