Job Purpose:
The Regulatory and Quality Affairs Manager will be responsible for ensuring that all FIND sponsored Human Subject Research (HSR) is compliant with applicable regulatory and quality requirements. He/she will be responsible for updating and maintaining FIND’s quality management systems and for overseeing all regulatory activities within the organization. He/she will be responsible for engaging with internal and external partners for regulatory and quality assurance matters.
Position Summary:
Detailed responsibilities:
• Leads the revision of the Clinical QMS, working with other FIND department and research teams for updates, improvements and new document creation.
• Identifies potential HSR level QM systemic gaps and coordinates with the appropriate stakeholder to ensure timely remediation. As appropriate, escalate issues of critical noncompliance and/or urgency for remediation to the senior management
• Provides expertise in ISO14155 / ISO20916 /ISO13485 to ensure the quality of studies conducted and sponsored by FIND.
• Provides QA support in oversight of partners, vendors, and clinical investigator sites while assessing compliance with local regulations, GCP/ISO requirements, study protocols and SOPs.
• Oversees and implements regulatory compliance for all products in portfolio (ISO 13485)
• Handles the submission, maintenance, and renewal of product approvals in various geographies
• Monitoring regulatory and legal requirements of target countries and keeping abreast with changes in requirements.
• Leads or assists with identifying non-compliances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology.
• Leads qualification, routine and for-cause audits of partners, investigator sites, laboratories and other vendors and collaborate with auditors and auditees to ensure appropriate implementation of Corrective and Preventive Action Plans (CAPAs)
• Advises on the need for internal audits (TMF, systems, processes, vendors, sites, computer system validation) and leads some of those as required.
• Oversees audit observations and CAPAs documentation and implementation.
• Supports interdisciplinary teams in regulatory matters.
• Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies
Experience/Skills required:
Qualification and Experience:
• Graduate or post graduate degree in an appropriate scientific discipline
• Min 5 years of professional experience in Regulatory Affairs (RA) and Quality Management (QM)
Knowledge, skills, and abilities:
• Working knowledge of tools, methods, and concepts of quality assurance
• Expert knowledge of IVDR, ISO9001, ISO 15189:2022, ISO 17025:2017 and ISO 13485
• Strong attention to details
• Experience with In vitro diagnostic (IVD) medical devices is a big plus
• Genuine team player with a positive mindset and result-oriented approach
• Flexibility, "hands-on" and "can do" attitude
• Ability to work independently and without close supervision
• Excellent interpersonal and communication skills and experience in working in a multi-cultural environment
• Excellent written and oral communication skills in English and French
• Advanced computer knowledge of MS Office programs
Apply Here:
https://finddx.intranet.digital/external/en/companies/37147673-4fa9-4747-8148-e8f7720fbd7d/jobs/a5b8f7e8-1d9e-48e3-bd64-6b75d48f17da/apply/a5b8f7e8-1d9e-48e3-bd64-6b75d48f17da