As a Principal Regulatory Compliance Consultant at our company based in Hyderabad, India, with a hybrid workplace type, your role involves leading compliance projects and activities while providing guidance to other Regulatory Compliance Consultants. Here are your key responsibilities:
Serving as a Subject Matter Expert for compliance topics, both internally and externally
Creating and updating SOPs following a strict document control process
Advising teams on best practices for meeting compliance requirements
Planning and performing internal audits as a lead auditor for frameworks including ISO 9001/27001/27017 and GxP requirements
Performing peer reviews for Audit Plans and Audit Reports generated by other team members
Representing the compliance team in external audits
Staying updated on industry compliance topics and identifying training needs
Performing CAPA resolution for the QRC team and assisting other teams with CAPA resolution for findings in their areas
Tracking metrics across compliance initiatives and suggesting opportunities for improvement
Leading formal Risk Assessment and Risk Remediation activities
Identifying the need for compliance projects based on industry trends and regulatory intelligence
Leading compliance projects from planning through completion, identifying resource needs and reporting on progress to meet assigned deadlines
Participating in initiatives to achieve new compliance as new requirements emerge (such as GDPR, NIS2, CRA)
For qualifications, you should have:
Education / Qualifications:
Bachelors degree in Computer Science, Engineering, or equivalent technical experience
5 to 10 years of 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
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
Certified lead auditor training for ISO 9001/13485 or ISO 27001
Skills required for the role include:
Audit: Experience planning and conducting internal audits, identifying nonconformities, writing audit reports, giving feedback, and tracking CAPA progress
Communication: Excellent verbal and written communication skills to effectively reach audiences with varying levels of compliance knowledge
Initiative: Ability to identify areas of need and propose solutions proactively
Coaching: Ability to effectively coach teams and peers on compliance topics
Independence: Structuring tasks and working independently with limited supervision
Project Leadership: Managing projects independently, including assessment of staff and tools needed, creation and assignment tasks, timelines and milestones, and reporting methods
Organization: Understanding requirements for record storage and planning for efficient retrieval during audits
As a company, Octave provides mission-critical software that enables organizations to make informed decisions throughout the asset lifecycle. With approximately 7,200 employees in 45 countries, Octave focuses on performance, safety, and reliability to improve resilience and incident response. If you join us, you can expect an environment that supports your ambitions and values diversity and inclusivity. As a Principal Regulatory Compliance Consultant at our company based in Hyderabad, India, with a hybrid workplace type, your role involves leading compliance projects and activities while providing guidance to other Regulatory Compliance Consultants. Here are your key responsibilities:
Serving as a Subject Matter Expert for compliance topics, both internally and externally
Creating and updating SOPs following a strict document control process
Advising teams on best practices for meeting compliance requirements
Planning and performing internal audits as a lead auditor for frameworks including ISO 9001/27001/27017 and GxP requirements
Performing peer reviews for Audit Plans and Audit Reports generated by other team members
Representing the compliance team in external audits
Staying updated on industry compliance topics and identifying training needs
Performing CAPA resolution for the QRC team and assisting other teams with CAPA resolution for findings in their areas
Tracking metrics across compliance initiatives and suggesting opportunities for improvement
Leading formal Risk Assessment and Risk Remediation activities
Identifying the need for compliance projects based on industry trends and regulatory intelligence
Leading compliance projects from planning through completion, identifying resource needs and reporting on progress to meet assigned deadlines
Participating in initiatives to achieve new compliance as new requirements emerge (such as GDPR, NIS2, CRA)
For qualifications, you should have: