Principal Regulatory Compliance Consultant

Intergraph Corporation; Madison (AL); Remote; USD 80,000 - 100,000; Full time

Job summary

A leading technology company is seeking a Regulatory Compliance Consultant in Madison, Alabama. The role involves leading compliance projects, serving as a Subject Matter Expert, and performing internal audits. Candidates should have a Bachelor's degree in a related field and 5-10 years of experience in quality or regulatory compliance. The position offers a remote work environment.

Qualifications

• 5 to 10 years of experience in quality, security, or regulatory compliance.
• Experience implementing policies and procedures following document control.
• Certified lead auditor training for ISO 9001/13485 or ISO 27001.

Responsibilities

• Lead compliance projects and provide guidance to consultants.
• Serve as a Subject Matter Expert for compliance topics.
• Plan and perform internal audits for various frameworks.

Skills

Excellent communication skills

Audit planning and conducting

Ability to work independently

Project management

Coaching teams

Risk assessment

Education

Bachelor’s degree in Computer Science, Engineering or equivalent

Job description

Job Location

Madison, Alabama-USA

Workplace Type: Remote

Business Unit: ALI

Responsibilities

• Lead compliance projects and activities, and provide guidance to other Regulatory Compliance Consultants.
• Serve internal and external customers as a Subject Matter Expert for compliance topics
• Create and update SOPs following a strict document control process
• Advise teams on best practices for meeting compliance requirements
• Plan and perform internal audits as a lead auditor for frameworks including, but not limited to, ISO 9001/27001/27017 and GxP requirements
• Perform peer reviews for Audit Plans and Audit Reports generated by other team members
• Represent the compliance team in external audits
• Stay abreast of industry compliance topics and identify training needs
• Perform CAPA resolution for the QRC team and assist other teams with CAPA resolution for findings in their areas
• Track metrics across compliance initiatives and suggest opportunities for improvement
• Lead formal Risk Assessment and Risk Remediation activities
• Identify the need for compliance projects, based on industry trends and regulatory intelligence
• Lead compliance projects from planning through completion, identifying resource needs and reporting on progress to meet assigned deadlines
• Participate in initiatives to achieve new compliance as new requirements emerge (such as GDPR, NIS2, CRA)

Education / Qualifications

• Audit: Experience planning and conducting internal audits, identifying nonconformities, writing audit reports, giving feedback, and tracking CAPA progress.
• Communication: Excellent communication skills, both verbal and written, with the ability to effectively reach audiences with varying levels of compliance knowledge
• Initiative: Ability to identify areas of need and propose solutions without being prompted
• Coaching: Ability to effectively coach teams and peers on compliance topics
• Independence: Must be able to structure own tasks and work independently, with limited supervision
• Project Leadership: Ability to manage projects independently, including assessment of staff and tools needed, creation and assignment tasks, timelines and milestones, and reporting methods
• Organization: Must understand requirements for record storage and plan for efficient retrieval during audit
• Bachelor’s degree in Computer Science, Engineering or equivalent technical experience
• At least 5 to 10 years experience in quality, security or regulatory compliance
• Experience implementing policies and procedures following document control
• Experience performing internal audits against ISO 27001
• Experience hosting customer and/or 3rd party certification audits
• Certified lead auditor training for ISO 9001/13485 or ISO 27001

About Hexagon

Hexagon is the global leader in enterprise software, empowering organizations to build a safer, more sustainable and efficient future.

Equal Employment Opportunity

Hexagon is an equal opportunities employer and welcomes applications from diverse candidates.