Clinical Compliance Manager
About The Position
The Clinical Compliance Manager will maintain clinical compliance and organizational audit readiness as 4C advances pivotal clinical trials and prepares for commercialization. The role partners with Clinical Affairs, Quality, Regulatory, and other functional teams to prepare for and support internal and external audits, regulatory inspections, notified body assessments, and quality system assessments. This hands-on role identifies compliance gaps, strengthens processes, and helps develop practices and systems for a growing medical device organization. Responsibilities include reviewing clinical documentation and records, coordinating audit activities, supporting applicable regulatory and quality requirements, tracking corrective actions, and helping ensure ongoing audit readiness. The role also supports clinical training and qualification records, Trial Master File oversight, clinical data protection procedures, and regular leadership updates on readiness, risks, and remediation progress. The position is primarily office-based in a collaborative, fast-paced startup environment. Occasional domestic or international travel may be required to support audits, clinical sites, or regulatory activities, with travel expected up to 20%. Flexibility may be needed to support audit timelines and regulatory deadlines.
Requirements
- Bachelor's degree in Life Sciences, Healthcare Administration, Quality Management, Regulatory Affairs, or a related field.
- 5+ years of experience in clinical compliance, clinical operations, or quality assurance within the medical device, pharmaceutical, or biotechnology industry.
- Experience supporting clinical trials in a regulated environment.
- Experience preparing for, coordinating, or participating in internal and external audits, regulatory inspections, or quality system assessments.
- Strong working knowledge of FDA regulations, ISO 14155, ISO 13485, EU MDR, and applicable Good Clinical Practice (GCP) requirements.
- Experience with audit management, document control, training management, and CAPA tracking systems.
- Proficiency with Microsoft Office and electronic quality management systems (eQMS).
- Strong documentation review, organizational, communication, and recordkeeping skills.
- Ability to manage competing priorities, work independently, and collaborate across functional teams.
Nice To Haves
- Experience within a medical device startup or growing organization with evolving processes and systems.
- Experience supporting FDA inspections, notified body assessments, surveillance audits, or recertification audits.
- Familiarity with Trial Master File (TMF) oversight, clinical data protection, vendor qualification, and clinical site documentation.
- Advanced degree or relevant industry certification, such as CCRP, CCRA, RAC, or CQA.
- Demonstrated accountability, attention to detail, adaptability, problem solving, and commitment to continuous improvement.
- Ability to communicate compliance risks and expectations clearly and work constructively with stakeholders at all levels.
Responsibilities
- Coordinate and support internal and external audits, regulatory inspections, notified body assessments, and quality system audits.
- Maintain ongoing audit readiness by reviewing clinical documentation, records, processes, and supporting evidence for completeness, accuracy, and compliance.
- Partner with Quality and Regulatory to support compliance with applicable FDA regulations, ISO 14155, ISO 13485, EU MDR, ICH-GCP, and other relevant requirements.
- Coordinate audit activities, including schedules, document requests, evidence collection, stakeholder preparation, and auditor communications.
- Review clinical trial documentation and processes to identify compliance gaps, inconsistencies, and opportunities for corrective action.
- Partner with functional leaders to document, track, and resolve audit findings, observations, CAPAs, and other compliance-related action items.
- Support the development and maintenance of clinical compliance procedures, work instructions, policies, and supporting documentation.
- Monitor required employee training, vendor qualifications and oversight, and other applicable training and qualification records.
- Support Trial Master File (TMF) oversight and the completeness of investigator site documentation and essential study records.
- Help ensure clinical data protection procedures are established, maintained, and consistently followed.
- Identify opportunities to strengthen compliance processes, documentation controls, and audit preparation as the organization scales.
- Provide leadership with regular updates on audit readiness, outstanding items, emerging risks, and remediation progress.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
