Senior Regulatory Compliance Analyst

Responsibilities

The Senior Regulatory Compliance Consultant works independently on compliance 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
• 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
• Participates in formal Risk Assessment and Risk Remediation activities
• Participates in initiatives to achieve new compliance as new requirements emerge (such as GDPR, NIS2)
  
  

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

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

Education / Qualifications

• Bachelor’s degree in Computer Science, Engineering or equivalent technical experience
• 3 to 5 years experience in quality, security or regulatory compliance
• Must have experience implementing policies and procedures following document control
• Must have experience performing internal audits for quality, security, or regulatory compliance
• 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
  
  

About Octave

Octave provides mission-critical software that empowers organizations to make informed decisions across every stage of the asset lifecycle - Design, Build, Operate and Protect - where performance, safety, and reliability are non-negotiable and failure is not an option.

Turning complex operational data into actionable intelligence, Octave connects expertise, real-world conditions and enterprise-scale insight to improve performance, resilience and incident response where it matters most.

Octave has more than 7,000 employees in 45 countries. Learn more at octave.com and follow us on LinkedIn.

Why work for Octave?

All in. Always forward. That's the way we do things around here. We put trust in our people because we believe it's the best way to unleash potential, bring ideas to life, and keep moving ahead. And it's why we're committed to creating an environment that's truly supportive, providing you with the resources you need to support your ambitions, no matter who you are or where you are in the world.

Everyone is welcome

At Octave, we believe that diverse and inclusive teams are critical to the success of our people and our business. Here, everyone is welcome. As an inclusive workplace, we don't 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're valued here.

Senior Regulatory Compliance Analyst

Job Location (Short): Hyderabad, India

Workplace Type: Hybrid

Req Id: 3022

About Octave

Octave provides mission-critical software that empowers organizations to make informed decisions across every stage of the asset lifecycle - Design, Build, Operate and Protect - where performance, safety, and reliability are non-negotiable and failure is not an option.

Turning complex operational data into actionable intelligence, Octave connects expertise, real-world conditions and enterprise-scale insight to improve performance, resilience and incident response where it matters most.

Octave has more than 7,000 employees in 45 countries. Learn more at octave.com and follow us on LinkedIn.

Why work for Octave?

All in. Always forward. That's the way we do things around here. We put trust in our people because we believe it's the best way to unleash potential, bring ideas to life, and keep moving ahead. And it's why we're committed to creating an environment that's truly supportive, providing you with the resources you need to support your ambitions, no matter who you are or where you are in the world.

Everyone is welcome

At Octave, we believe that diverse and inclusive teams are critical to the success of our people and our business. Here, everyone is welcome. As an inclusive workplace, we don't 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're valued here.

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