Regulatory Affairs Learner

Boston Scientific Gruppe; Johannesburg; On-site; ZAR 200,000 - 300,000; Full time

Job summary

A leading medical technology company is seeking a Regulatory Affairs Learner in Johannesburg. Responsibilities include managing product registrations and ensuring regulatory compliance in South Africa and other regional markets. Ideal candidates will have a Bachelor’s degree in a relevant field and strong analytical abilities. This position offers opportunities for growth in a dynamic environment.

Qualifications

• Bachelor’s degree in relevant field required.
• Master’s degree or relevant certification is highly advantageous.
• Flexibility and adaptability to changing environments.

Responsibilities

• Manage product registration and approval processes for South African and regional markets.
• Prepare and coordinate submission documentation with stakeholders.
• Ensure compliance with South African regulations.

Skills

Problem-solving

Analytical abilities

Interpersonal skills

Attention to detail

Teamwork

Education

Bachelor’s degree in Health Science, Microbiology, Biochemistry, Chemistry, or related field

Master’s degree or relevant certification

Tools

MS Word

Excel

PowerPoint

Job description

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Regulatory Affairs Learner, South Africa

Purpose Statement

Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation. Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation. Provide management team with regular updates on product registration and new regulations from government body.

Key Responsibilities:

Manage product registration and approval processes for local and export markets (South Africa, Kenya, Ghana, Botswana, Ivory Coast, Tanzania).

Prepare and coordinate submission documentation with distributors, competent authorities, and authorized representatives.

Track registration statuses and facilitate product releases with the global team and supply chain.

Ensure compliance with South African regulations (SAHPRA, ICASA, DOH) and manage amendments and registrations accordingly.

Communicate regulatory updates and changes to relevant internal and external stakeholders.

Review and approve promotional materials to ensure compliance with marketing codes and regulations.

Maintain and update regulatory SOPs, records, and change notifications.

Support post-market activities including incident reporting and closure with regulatory authorities.

Provide regulatory documentation for tender bids, audits, market access, and reimbursement applications.

Ensure regulatory training compliance and maintain up-to-date records for audits.

Qualifications :

Bachelor’s degree in Health Science, Microbiology, Biochemistry, Chemistry, or related field.

Master’s degree or relevant certification is highly advantageous.

Strong problem-solving and analytical abilities.

Flexibility and adaptability to changing environments.

Excellent interpersonal and communication skills.

Effective task planning and prioritization.

Attention to detail and accuracy.

Technical understanding of regulatory and product-related issues.

Teamwork and collaboration skills.

Proficiency in MS Word, Excel, PowerPoint, email, and internet tools.

Requisition ID:610362

Job Segment: Regulatory Affairs, Compliance, Supply Chain, Biochemistry, Microbiology, Legal, Operations, Science