Regulatory Affairs Specialist Africa

At Terumo Blood and Cell Technologies, our 7,900+ team members play an important role in the collection, processing, development, and delivery of those blood- and cell-based treatments – so our customers can help more patients access the highest standards of care.

Regulatory Affairs Specialist Africa

JOB SUMMARY

• The Regulatory Affairs Specialist is responsible for developing and executing regulatory strategies to obtain and maintain medical device registrations across African markets. The role supports business growth by ensuring compliance with applicable regulatory requirements and facilitating timely market access for medical devices throughout the African continent.

• The specialist serves as the primary regulatory contact for submissions, renewals, variations, and post-registration activities with national regulatory authorities and local representatives. The position requires a strong understanding of African medical device regulations, regional harmonization initiatives, quality management systems, and international regulatory standards.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Regulatory Strategy and Submissions:

• Prepare, compile, review, and submit medical device registration dossiers to health authorities across Africa.

• Develop regulatory submission strategies to support product launches and business objectives.

• Coordinate new registrations, renewals, amendments, change notifications, and license maintenance activities.

• Manage regulatory timelines and ensure timely approvals and renewals.

• Support commercialization efforts by providing regulatory guidance for new product introductions.

Compliance and Documentation:

• Maintain up-to-date knowledge of global regulatory requirements and ensure company practices align with these standards.

• Ensure proper documentation and maintenance of regulatory files and records.

Authority and Distributor Management:

• Act as the primary contact with regulatory authorities, notified entities, local representatives, and distributors.

• Coordinate responses to authority questions, deficiency letters, and requests for additional information.

• Support distributor qualification and regulatory oversight activities.

• Facilitate interactions during inspections, audits, and authority meetings.

Regulatory Intelligence:

• Stay informed of changes in the regulatory landscape and communicate potential impacts to senior management and other stakeholders.

• Participate in industry forums, conferences, and working groups to represent the company and gain insights into emerging regulatory trends.

• Provides key guidance on regulatory topics to cross functional

MINIMUM QUALIFICATION REQUIREMENTS

Education