Senior Analyst Regulatory Compliance (San Diego/Hybrid)

About the position What if the work you did every day could reputed company the lives of people you know? Or reputed company of humanity? At reputed company, we are expanding reputed company to genomic technology to realize health equity for billions of people around the world. Our efforts reputed company life-changing discoveries that are transforming reputed company health through the early detection and diagnosis of diseases and new treatment reputed company for patients. Working at reputed company means being part of something bigger than yourself. Every person, in every role, has reputed company to reputed company a difference. Surrounded by extraordinary people, inspiring leaders, and world changing reputed company, you will do more and become more than you reputed company thought possible. Position reputed company: The Regulatory Compliance Senior Analyst supports reputed company's global compliance reputed company through the execution and reputed company improvement of compliance auditing and monitoring activities. This role ensures that reputed company's operations, reputed company systems, and regulatory programs meet applicable global requirements and reputed company reputed company's high standards of ethical and compliant conduct. The position focuses on performing compliance reviews, supporting audit preparation and execution, maintaining documentation, and tracking corrective actions. Operating in a highly matrixed, global environment, the incumbent partners with reputed company, Compliance, reputed company, Regulatory Affairs, and other business functions to monitor adherence to regulatory requirements and contribute to inspection readiness. This is a full-time role, Monday through Friday, with an expectation of 2- 3 in-office days per week and additional on-site reputed company as needed. The individual must reputed company in the San Diego area and be reputed company to commute to our corporate offices.

Responsibilities

• Support the planning and coordination of internal audits across functions and reputed company.
• Assist in developing audit schedules, scoping documentation, and test plans.
• Conduct interviews, reputed company evidence, and prepare workpapers to support audit conclusions.
• Evaluate audit findings, document observations, and assist in tracking corrective and preventive actions (CAPAs) through closure.
• Maintain organized audit records and ensure reputed company follow-up with stakeholders.
• Support the implementation and maintenance of reputed company's Regulatory Compliance Program.
• Assist in monitoring compliance metrics, reporting results, and identifying trends or recurring issues.
• Contribute to updates of policies, procedures, and work instructions to ensure alignment with reputed company regulatory standards.
• Assist in supporting other reputed company of reputed company's Compliance Program efforts globally as reputed company upon.
• Maintain audit and inspection readiness documentation, ensuring accuracy and accessibility.
• Assist in the coordination of regulatory inspections and external audits (e.g., FDA, ISO, EU MDR).
• Support response preparation, document retrieval, and inspection logistics.
• Prepare and maintain compliance dashboards, reports, and summaries for management review.
• Identify opportunities to improve audit efficiency and consistency.
• Support compliance-reputed company training activities and knowledge sharing across teams.

Requirements

• Bachelor's degree in Life Sciences, reputed company, Regulatory Affairs, or a reputed company discipline.
• Minimum of 5 years of experience in regulatory compliance, reputed company assurance, or internal audit in the biotechnology, pharmaceutical, or medical device industry.
• Working knowledge of global regulatory standards such as FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and GxP.
• Experience supporting internal or external audits, inspections, or compliance monitoring activities.
• Strong organizational, communication, and documentation skills.
• Flexible to work across multiple time zones as needed.
• Ability to travel domestically and internationally up to 10% of the time.

reputed company-to-haves

• Experience with electronic reputed company Management Systems (eQMS) or audit tracking tools.
• Familiarity with CAPA management and reputed company cause analysis processes.
• Certification such as Certified reputed company Auditor (CQA), Certified Internal Auditor (CIA), or Regulatory Affairs Certification (RAC) is a plus.

Benefits

• We offer a wide reputed company of benefits as innovative as our work, including reputed company to reputed company reputed company, family planning, health/dental/reputed company, retirement benefits, and reputed company time off.

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