Principal Regulatory Compliance Consultant

Responsibilities

The Principal Regulatory Compliance Consultant leads compliance projects and activities, and provides guidance to other Regulatory Compliance Consultants.

• Serves internal and external customers as a Subject Matter Expert for compliance topics
• Creates and updates SOPs following a strict document control process
• Advises teams on best practices for meeting compliance requirements
• Plans and performs internal audits as a lead auditor for frameworks including, but not limited to, ISO 9001/27001/27017 and GxP requirements
• Performs peer reviews for Audit Plans and Audit Reports generated by other team members
• Represents the compliance team in external audits
• Stays abreast of industry compliance topics and identifies training needs
• Performs CAPA resolution for the QRC team and assists other teams with CAPA resolution for findings in their areas
• Tracks metrics across compliance initiatives and suggests opportunities for improvement
• Leads formal Risk Assessment and Risk Remediation activities
• Identifies the need for compliance projects, based on industry trends and regulatory intelligence
• Leads compliance projects from planning through completion, identifying resource needs and reporting on progress to meet assigned deadlines
• Participates in initiatives to achieve new compliance as new requirements emerge (such as GDPR, NIS2, CRA)
  
  

Qualifications

Education / Qualifications

• Bachelor’s degree in Computer Science, Engineering or equivalent technical experience
• Must have at least 5 to 10 years experience in quality, security or regulatory compliance
• Must have experience implementing policies and procedures following document control
• Must have experience performing internal audits against ISO 27001
• Must have experience hosting customer and/or 3rd party certification audits
• GxP experience (FDA or EMA) in QMS, ISMS or Validation a plus
• ISO 42001 or other compliance framework for AI a plus
• NIS2 experience a plus
• Must have passed certified lead auditor training for ISO 9001/13485 or ISO 27001
  
  

Skills

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
• Reporting methods
  
  

Organization: Must understand requirements for record storage and plan for efficient retrieval during audit

About Hexagon

Hexagon is the global leader in enterprise software, empowering organizations to build a safer, more sustainable and efficient future. We transform complex data into actionable insights that drive smarter decisions, modernize operations and accelerate digital maturity across industries that matter most — public safety, defense, transportation, government, industrial facilities and physical security.

Hexagon (Nasdaq Stockholm: HEXA B) has approximately 24,800 employees in 50 countries and net sales of approximately 5.4bn EUR. Learn more at hexagon.com.

Why work for Hexagon?

At Hexagon, if you can see it, you can do it. Hexagon puts their trust in you so that you can bring your ideas to life. We have emerged as one of the most engaged and enabled workplaces*. We are committed to creating an environment that is truly supportive by providing the resources you need to fully support your ambitions, no matter who you are or where you are in the world.

• In the recently concluded workplace effectiveness survey by Korn Ferry, a global HR advisory firm, Hexagon, has emerged as one of the most Engaged and Enabled workplaces, when compared to similar organizations that Korn Ferry partners with.
  
  

Everyone is welcome

At Hexagon, we believe that diverse and inclusive teams are critical to the success of our people and our business. Everyone is welcome—as an inclusive workplace, we do not discriminate. In fact, we embrace differences and are fully committed to creating equal opportunities, an inclusive environment, and fairness for all.

Respect is the cornerstone of how we operate, so speak up and be yourself. You are valued here.

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