Quality and Regulatory Affairs Manager

A world leader in the field of in vitro diagnostics for more than 60 years, bioMérieux provides diagnostic solutions which determine the source of disease and contamination to improve patient health and ensure consumer safety.

Our teams working across our digital transformation and information technology areas are literally changing healthcare through technology. Their various expertises are serving innovations for patients and business. Development of new solutions (hardware and software) as well as building qualitative data and insights contribute to the constant improvement of public health.

Come and join a family-owned global company with a long-term vision, and a human-centered culture.

Primary Purpose and Overall Objective of the Job:

The position reports to the Africa Regional Quality/Regulatory Director. Its main responsibility is executing Quality and Regulatory tasks AT bioMérieux for all markets that export distributors cover; To execute Quality and Regulatory Strategies; ensure adherence to policies and drive implementation of the Quality processes as planned at the project/program level. Accountable for Country Office/Distributor Management Objectives, you lead programs at the country or Distributor for developing, implementing, and continually improving systems to ensure customer requirements are implemented into company processes and services provided.

The position will also be responsible for administrating the registration portfolio for markets within scope, assisting with local regulatory surveillance activities, and routine management of the Quality Management System.

Main Accountabilities:

Quality Management System Representative

• Responsible to implement corporate quality policy at the distributor level.
• Assist with the routine management of the Quality Management System
• Responsible to implement quality objectives in the distributor: Communicate, share, and contribute to Corporate Quality Objectives, defining and reporting company KPIs as required.
• Accountable and responsible for defining and implementing quality objectives assisting the distributor to meet their Quality Obligations laid out in the FDA.
• Responsible to highlight the resources needed to accomplish the Quality and Regulatory objectives.
• Responsible to define and ensure appropriate quality training for the distributor (newcomers & yearly training plan): Make sure quality training needs are identified and, quality training plan is established and followed-up.
• Accountable and responsible to inform staff of new procedures and effectively checking that they are implemented with sufficient training.
• Make sure processes needed for the Quality Management System are described and their performance is regularly assessed via a documented quality management review process.
• Accountable to manage external and internal audit processes to ensure inspection readiness, identify audit needs, Establishing Internal audit schedule, allocate resources (including qualification of internal auditors), and follow-up.
• Accountable to ensure that the "complaint handling process" is in place and effective in the distributor.
• Accountable and responsible to help manage the distributor CAPA process where relevant to the specific role.
• Accountable and responsible to manage documentation using global document management tools.
• Accountable and responsible to manage change management process for the country office where relevant.
• Accountable and responsible to manage customer satisfaction surveys.
• Accountable and responsible for supplier approval for the subsidiary, assuring continued supplier qualification
• Responsible to manage Field Actions (FCA/FSCA/MAR/PSS/PRS) for export distributors.
• Responsible for vigilance (adverse events reporting) in the country office. In other jurisdictions, this responsibility may fall with the distributor as part of their contractual obligation.
• Accountable and responsible to monitor the local regulatory environment.
• Responsible for reporting to authorities, and communication with customers, third parties and authorities where required regarding quality. This responsibility may be taken up by distributors as part of their contractual obligation in some jurisdictions (e.g. Country offices).
• Responsible to schedule management review, organize, coordinate collection of data from process owner and prepare management Review, analyze the data, summarize and prepare the output from Management Review, submit for approval to the head of the Subsidiary for QMR’s based in the Subsidiary. Contribute as needed to the Cluster Quality Management Review.

Regulatory Compliance Representative

• Assess continuously Project output with consideration to evolving regulations; assess the impact on resources and launch dates; adapt regulatory strategy and give feedback to the project,
• Manage and monitor Regulatory processes at the Project/Product Portfolio level to ensure timely execution,
• Assist in the development of answers to questions and in the interactions/negotiations with regulatory agencies of their representatives; review progress and report on issues,
• Provide feedback on the effectiveness of the regulatory processes (strategy, applications review with questions/answers, issues and problem resolution) and contribute to the improvement plan.
• Leads or facilitates teams to accomplish the deliverables, milestones, and objectives meeting the plans and schedules ensuring that any changes to the plans are communicated and agreed to by the teams and project sponsors. Facilitate risk avoidance/management analysis and crisis management.
• Determines compliance status to regulations and standards of operating departments and recommends corrective/improvement actions.

Studies-Experience:

• Bachelor of Science Degree in a Medical, Scientific, or Engineering Subject with 0-4 years’ work experience or equivalent experience in industry.
• Ability to work independently and in a team environment.

Skills and Qualifications:

• Good leadership and communication skills.
• Experience in participation in the management of regulatory audits (e.g. ISO 9001, ISO 13485, etc.).
• Knowledge in the interpretation and application of relevant Domestic and International Regulations and Industry Standards (e.g. ISO, QSR, IVDR, AFNOR etc.).
• Excellent verbal and written communication skills, ability to analyze and use data to drive decisions. Excellent organizational and administrative skills.

Location: Abidjan, Cote Divoire

Language: Written/Spoken fluency in English and French is a mandatory prerequisite.

bioMérieux welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.