Senior Biological Safety & Compliance Specialist

ICU Medical-posted 4 months ago
$120,000 - $161,250/Yr
Full-time • Senior
San Clemente, CA
Merchant Wholesalers, Durable Goods
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This position is responsible for ensuring compliance with design control and biological safety standards across the product lifecycle, including authoring and maintaining technical and regulatory documentation to support manufacturing changes, material substitutions, and validation activities. The role involves developing risk-based test strategies, conducting impact assessments, and preparing audit-ready materials in accordance with industry regulations such as ISO 14971 and ISO 10993. Additionally, the position supports internal compliance monitoring, audit preparations, and risk analysis efforts by implementing structured frameworks for evaluating and documenting regulatory impacts, validation needs, and compliance risks associated with engineering and process changes.

  • Oversee the development and maintenance of biological safety documentation in accordance with industry regulations and internal standards.
  • Draft and author technical documentation to support manufacturing process changes, material substitutions, and other product lifecycle modifications, ensuring scientific rationale and regulatory alignment.
  • Prepare and justify material change requests (MCRs) and manufacturing change documentation, including risk assessments, biological safety evaluations, and regulatory impact analyses.
  • Develop and author test strategies and validation protocols to support Operations team initiatives involving supplier changes, manufacturing process modifications, and equipment replacements within sustaining engineering projects.
  • Conduct impact assessments for proposed changes, determining appropriate levels of verification and validation (V&V) required based on risk and regulatory requirements.
  • Support root cause analysis and corrective actions by contributing to test method development, validation, and troubleshooting during sustaining efforts.
  • Support audit preparations and maintain documentation related to biological safety compliance.
  • Draft and maintain audit preparation strategy documentation to support readiness for internal and external audits focused on risk management, biological safety, and compliance with industry regulations (e.g., ISO 14971, ISO 10993).
  • Develop and implement internal compliance monitoring programs that proactively identify gaps in risk management files, biological safety assessments, and associated documentation.
  • Author and maintain procedures and work instructions that strengthen audit readiness and reduce the likelihood of non-conformances (NCRs) related to Engineering Change Orders (ECOs) and biological safety validation testing.
  • Draft and author change notification documentation (e.g., Change Notices, Engineering Change Orders) that clearly outlines the rationale and justification for manufacturing process changes, material substitutions, and product design updates.
  • Conduct impact assessments to determine the need for additional validation or verification testing, including biocompatibility, sterilization, shelf-life, or performance testing based on the nature of the change.
  • Identify and document regulatory and risk implications associated with proposed changes, including potential effects on previously approved product filings or market clearances.
  • Assist in defining test strategies or rationales for test exemptions in alignment with change impact outcomes and historical performance data.
  • Draft and author risk-benefit analysis documentation to support decision-making for product, process, and material changes, ensuring alignment with regulatory expectations (e.g., ISO 14971, FDA risk-based approach).
  • Develop structured documentation that defines a scoring or scaling system for assessing the compliance risk associated with process, supplier, and material changes, guiding when validation or re-validation testing (e.g., biocompatibility, functional, or process validation) is required.
  • Establish and maintain risk evaluation criteria that incorporate product classification, patient exposure, intended use, and historical data to ensure consistent risk categorization across sustaining and development projects.
  • Extensive knowledge and experience in design control and biological safety with regard to assessment, testing, and risk evaluation for class II or III medical devices.
  • Excellent documentation, communication, and interpersonal relationship skills including negotiation and relationship management with ability to drive achievement of objectives.
  • Deep understanding of ISO 14971 and ISO 10993, FDA guidelines, EU regulations, and other international standards.
  • Demonstrated capability of managing, leading, and developing direct reports.
  • Experience reading, analyzing, and interpreting common scientific and technical journals/literature, scientific procedures and regulatory guidelines, and writing technical reports.
  • Able to work quickly and effectively in a fast-paced, dynamic work environment.
  • High level of attention to detail.
  • Able to multitask, work under pressure in a fast-paced environment and meet deadlines.
  • Excellent problem solving and decision-making skills.
  • Proficient in the use Microsoft Office tools - Word, Office, Power Point, and Outlook.
  • Salary range: $120,000 - $161,250
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