Senior Manager Quality & Regulatory Affairs

Senior Manager Quality & Regulatory Affairs

Established in 2003, FIND is a global nonprofit dedicated to ensuring equitable access to diagnostics, based in Geneva, Switzerland, but also has regional offices in India, Kenya, South Africa, and Viet Nam.

We connect countries and communities, funders, decision-makers, healthcare providers and developers to spur diagnostic innovation and make testing an integral part of sustainable, resilient health systems.

For more than 20 years, FIND has been at the forefront of revolutionizing diagnostics, particularly in the realm of infectious diseases, bringing lower-cost, quality diagnosis to those who need it as an essential component of universal health care while also leading efforts in pandemic preparedness, and driving access to essential tools as a recognized thought leader.

Position summary:

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.

Detailed responsibilities

1. Leads the revision of the Clinical QMS, working with other FIND department and research teams for updates, improvements and new document creation.
2. 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.
3. Provides expertise in ISO14155 / ISO20916 / ISO13485 to ensure the quality of studies conducted and sponsored by FIND.
4. 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.
5. Oversees and implements regulatory compliance for all products in portfolio (ISO 13485).
6. Handles the submission, maintenance, and renewal of product approvals in various geographies.
7. Monitoring regulatory and legal requirements of target countries and keeping abreast with changes in requirements.
8. Leads or assists with identifying non-compliances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology.
9. 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).
10. Advises on the need for internal audits (TMF, systems, processes, vendors, sites, computer system validation) and leads some of those as required.
11. Oversees audit observations and CAPAs documentation and implementation.
12. Supports interdisciplinary teams in regulatory matters.
13. Maintains and demonstrates understanding of global standards, regulations, and regulatory bodies.

Qualification and Experience

1. Graduate or post graduate degree in an appropriate scientific discipline.
2. Min 5 years of professional experience in Regulatory Affairs (RA) and Quality Management (QM).

Knowledge, skills, and abilities

1. Working knowledge of tools, methods, and concepts of quality assurance.
2. Expert knowledge of IVDR, ISO9001, ISO 15189:2022, ISO 17025:2017 and ISO 13485.
3. Strong attention to details.
4. Experience with In vitro diagnostic (IVD) medical devices is a big plus.
5. Genuine team player with a positive mindset and result-oriented approach.
6. Flexibility, „hands-on“ and „can do“ attitude.
7. Ability to work independently and without close supervision.
8. Excellent interpersonal and communication skills and experience in working in a multi-cultural environment.
9. Excellent written and oral communication skills in English and French.
10. Advanced computer knowledge of MS Office programs.

Applications should be sent to via e-mail only.

Please enclose the following documents:

1. CV,
2. Cover letter expressing your interests, explaining why you are suitable for this position, and stating your expected monthly salary,
3. Contact details of two professional referees.

FIND is an Equal Opportunity Employer, and celebrates fostering a collaborative, diverse, and inclusive work environment. All persons will be considered for employment regardless of race, color, creed, national origin, ancestry, gender, gender identity or expression, national origin, parental status, veteran status, marital status, disability, religious or political affiliation, age or sexual orientation shall have equal access to positions, limited only by their ability to do the job.

FIND has clear safeguarding and protection guidelines with zero tolerance for any forms of abuse and exploitation.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Project Management, Consulting, and Management

Industries

Public Health, Non-profit Organizations, and Hospitals and Health Care

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