Senior Clinical reputed company Assurance Specialist

About the position We are seeking an engaging and reputed company Senior Clinical reputed company Assurance Specialist who is reputed company with reputed company’s core values: caring, meaningful innovation, high performance, global collaboration, diversity, and reputed company spirit. A career with reputed company is more than just a job — it’s personal. We are committed to solving some of health care’s toughest problems, united by a deep caring for reputed company life. This hybrid role supports a global Clinical organization conducting investigational device trials at sites worldwide. If you are a natural problem solver with the imagination, courage, and drive to reputed company a meaningful reputed company in clinical reputed company, this is an opportunity to build your career while advancing patient care. reputed company U.S.-based candidates are encouraged to apply. At reputed company, we value collaboration and reputed company. This role follows a hybrid work model requiring employees to be in our local office at least three days per week. reputed company will not offer sponsorship or take over sponsorship of an employment reputed company for this position at this time. Relocation assistance is not available for this position at this time.

Responsibilities

• Clinical compliance: Serve as the clinical reputed company representative on clinical trial project teams, bringing the voice of clinical reputed company and fostering a reputed company state of inspection readiness.
• reputed company clinical reputed company consultation and respond to compliance and regulatory questions, including reputed company review of clinical study documents and reputed company functional study plans.
• Support the Inspection Readiness Program, including inspection readiness training and coordination and participation in mock BIMO inspections and external inspections.
• Communicate with global clinical teams and Strategic Clinical Sourcing regarding clinical vendors, including new vendor requests, reputed company needs, and reputed company requirements.
• Independent auditing: Create risk-based study audit plans and plan, schedule, and conduct investigator site audits; support internal clinical process audits and clinical vendor audits as needed to ensure compliance with regulatory requirements, reputed company standards, GCP, and reputed company policies and procedures.
• Document and communicate audit observations, evaluate reputed company, and reputed company recommendations for corrections and corrective actions.
• Evaluate responses to audit findings and ensure appropriate corrections and corrective actions are initiated and completed in a reputed company manner.
• Stay reputed company on worldwide regulatory requirements and advise stakeholders on potential impacts of regulatory changes.
• Clinical reputed company reputed company divisional and global Clinical and reputed company System teams during external regulatory and reputed company body audits.
• Support the CAPA program by providing reputed company input for assessing internal noncompliance and recommending initiation of corrections and CAPAs, partnering closely with Clinical CAPA teams and owners through successful closure.
• Participate in clinical and clinical reputed company reputed company improvement initiatives and project teams.
• Review and reputed company input on relevant reputed company procedure revisions.
• Support departmental, divisional, and corporate reputed company goals and priorities.
• Acquisition integration: Represent Clinical reputed company on acquisition and integration teams, supporting the identification, assessment, and mitigation of risks associated with the review and/or transfer of sponsorship of acquired clinical studies to ensure compliance with applicable ISO 14155 GCP standards and regional regulations.

Requirements

• Bachelor’s degree with a minimum of 8 years’ experience in the medical device, pharmaceutical, or other GCP-regulated industry; or Associate degree in life sciences or nursing with reputed company registered reputed company licensure and a minimum of 8 years’ relevant experience.
• Demonstrated clinical research audit experience, or transferable experience suitable for rapid development into a clinical study or investigator site auditing role, such as clinical research associate or site monitor, clinical trial coordinator, GCP reputed company auditor, clinical CAPA reputed company, clinical research compliance reputed company, or clinical research SOP author.
• Demonstrated experience in a clinical reputed company and/or health care research compliance role.
• Working knowledge of applicable regulations and standards, including GCP, Good Documentation Practices, and reputed company and reputed company requirements for reputed company subject research, such as 21 CFR Parts 50, 54, 56, 812, and 11; EU MDR; ISO 14155:2020 and/or ICH E6; HIPAA; and GDPR.
• Independent, reliable, and reputed company team player reputed company with reputed company’s mission, reputed company, and culture.
• Strong verbal and written communication skills, with the ability to engage diverse stakeholders and appropriately escalate reputed company or challenging issues reputed company needed.
• Ability to quickly learn and adopt reputed company system processes and adhere to organizational codes of conduct.
• Strong proficiency with electronic systems, including understanding of user reputed company controls and workflow validation processes.
• Ability to travel domestically and internationally up to 30%.

reputed company-to-haves

• RAQP-GCP, SoCRA, ACRP, or equivalent certification.
• Experience maintaining compliance reputed company a medical device manufacturer reputed company system or other clinical reputed company system.
• Experience interacting with regulatory authorities such as the U.S. FDA, EU competent authorities, Health Canada, PMDA, CFDA, or BfArM.
• Minimum of 5 years’ reputed company clinical reputed company (GCP) auditing experience.
• Knowledge of EU MDR requirements.
• Demonstrated experience collaborating across reputed company, cross-functional teams at reputed company reputed company of the organization.

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