Regulatory Affairs Specialist Africa at Terumo BCT

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

• Bachelor's degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, or related scientific discipline.
• Advanced degree or Regulatory Affairs certification is an advantage.

Experience

•  3 to 7 years of regulatory affairs experience within the medical device industry.
• Demonstrated experience managing medical device registrations in multiple African markets.
• Experience with Class I, II, III, and/or IV medical devices preferred.
• Experience working with distributors and local regulatory representatives.
• In depth knowledge of African medical device regulatory frameworks.
• Working knowledge of and ability to prepare regulatory documentation.

Knowledge of:

• ISO 13485
• ISO 14971
• MDR/IVDR principles
• Global Medical Device Nomenclature (GMDN)
• IMDRF guidance documents
• Medical device technical documentation requirements
• Experience dealing with notified bodies and competent authorities
• Proven track record in managing MDR submissions and handling communications with external authorities (CA and notified body)
• Technical documentation management
• Ability to perform change assessment for changes impacting EMEA countries

Skills

In line with Terumo's Core Values:

• Demonstrated and effective leadership and team skills.
• Demonstrated ability to define problems and work with management to develop and implement solutions.
• A high level of initiative as well as willingness to take ownership and accept responsibility for actions and decisions.
• Demonstrated ability to interact with diplomacy and tact while maintaining appropriate assertiveness and persistence.
• Demonstrated analytical and creative thinking skills and the ability to solve complex problems.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Demonstrated interpersonal skills and the ability to represent the business in contacts with those both internal and external to the organization.
• Exhibits commitment to organizational goals and guiding principles.

ADDITIONAL INFORMATION

• Please note that employment is offered on a contractor basis only (min. 6 months)
• Based: Kenya
• Reporting to:  Regulatory Affairs Director- EMEA