Principal Regulatory Compliance ConsultantIntergraph Corporation • Madison, AL, US
Principal Regulatory Compliance Consultant
Intergraph Corporation • Madison, AL, US
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionAudit : 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
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
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.
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