Compliance Engineer

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November 8

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MasterControl Japan

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SaaS • Pharmaceuticals • Biotechnology

MasterControl Japan is a local branch of MasterControl that provides cloud-based quality management (QMS), manufacturing execution (MES), and AI-enabled platform solutions for regulated industries. It helps pharmaceutical, biotechnology, medical device, food and government life-science organizations automate document control, audit and training management, CAPA, electronic batch records (EBR/eDHR), validation, supplier and post-market management, and data analytics to ensure compliance, improve product quality, and accelerate time-to-market. The company also offers the ADAPT AI platform, MasterControl Insights analytics, industry-specific implementations, seminars and resources in Japan.

201 - 500 employees

☁️ SaaS

💊 Pharmaceuticals

🧬 Biotechnology

📋 Description

• Develop, implement, and maintain compliance programs to ensure adherence to industry standards and regulatory requirements (e.g., FDA, ISO, GDPR, HIPAA). • Conduct internal audits and assessments to evaluate compliance with regulatory requirements and company policies. • Identify compliance risks and work with relevant departments to develop and implement corrective actions. • Provide guidance and training to employees on compliance matters, policies, and procedures. • Collaborate with cross-functional teams to ensure that compliance requirements are integrated into product development, manufacturing, and operational processes. • Monitor changes in regulatory requirements and industry standards, and update compliance programs and policies accordingly. • Prepare and maintain documentation related to compliance activities, including audit reports, risk assessments, and corrective action plans. • Support external audits and inspections by regulatory agencies and customers, ensuring that all necessary documentation and evidence are available. • Assist in the development and review of standard operating procedures (SOPs) to ensure compliance with regulatory requirements. • Analyze compliance data and metrics to identify trends and areas for improvement, and report findings to senior management. • Stay current with industry best practices and emerging trends in compliance engineering and regulatory affairs.

🎯 Requirements

• Proven experience in compliance engineering or a related role, with a strong understanding of regulatory requirements and industry standards (e.g., FDA, ISO, GDPR, HIPAA). • Strong analytical and problem-solving skills, with the ability to assess compliance risks and develop effective mitigation strategies. • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and provide clear guidance on compliance matters. • Detail-oriented and highly organized, with the ability to manage multiple tasks and priorities. • Proficiency in using compliance management software and tools. • Relevant industry certifications (e.g., Certified Compliance Engineer, Certified Regulatory Compliance Manager) are highly desirable. • Bachelor’s degree in Engineering, Quality Management, Regulatory Affairs, or a related field; advanced degree preferred.

🏖️ Benefits

• Competitive compensation • 100% medical premium coverage (yes, you read that right!) • 401(k) plan with company match • Generous PTO packages that increase with tenure • Schedule flexibility • Fitness clubs (you get paid to have fun and be active!) • Company parties and employee recognition programs • Wellness programs (free Fitbit, gym membership and athletic shoe reimbursements, etc.) • Onsite physician and massage therapist • Innovation center and gaming rooms at the office • Dental/vision plans • Employer paid life insurance policy • Much, much more!