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Senior Regulatory Compliance Analyst

Position Summary

The Senior Regulatory Compliance Analyst is responsible for supporting the establishment, control, and maintenance of compliance procedures and processes to ensure adherence to regulatory requirements and company compliance standards. The role supports and coordinates key Regulatory Compliance activities, working with moderate supervision and partnering with cross-functional teams across the site.

Key Responsibilities

• Support and coordinate external inspection and audit readiness activities, including preparation for regulatory inspections, Notified Body audits, FDA inspections, and corporate audits.
• Coordinate audit execution and support activities, including logistics, Front Room/Back Room support, SME preparation, communications, and responses to observations.
• Support the execution of the Internal Audit Program, including audit scheduling and execution, auditor qualification, and monitoring and improvement of audit metrics.
• Support investigations resulting from internal and external audits, including follow-up, effectiveness monitoring, and closure.
• Monitor and report Quality and Compliance metrics, identify adverse trends, support risk-based actions, and escalate compliance issues as appropriate.
• Support the implementation and continuous improvement of the Quality System, compliance standards, and new or revised regulatory requirements.
• Partner with Compliance teams and cross-functional stakeholders to strengthen compliance across the site.
• Provide Compliance education and training related to QSR, ISO, and GMP requirements, as needed.
• Support site Health, Safety, Environmental, and Compliance requirements and perform other responsibilities as assigned.

Qualifications & Experience

• Bachelor’s degree in Business Administration, Pharmacy, Biology, Engineering, Chemistry, or a related field.
• Training in Quality Auditing, ISO standards, and regulatory requirements.
• Minimum of 6 years of experience in the medical device or pharmaceutical industry, or equivalent experience in another regulated environment.
• Advanced English proficiency.

Skills

• Strong communication skills and ability to build credibility with different stakeholders.
• Ability to work effectively in complex and dynamic environments.
• Ability to make complex information clear and easy to understand.
• Technical understanding of products and processes, combined with business and compliance knowledge.
• Ability to support change and build strong internal and external partnerships.
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and has experience generating effective prompts to boost efficiency and productivity.

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