Remote-Ready Medical Device Regulatory Specialist

Placements24; Pretoria; Hybrid; ZAR 600,000 - 900,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits package

Remote work options

Professional growth opportunities

Job summary

Placements24 in Pretoria is seeking a detail-oriented Regulatory Affairs Specialist with medical devices expertise to join our client’s team. You will prepare regulatory dossiers, liaise with SAHPRA and other authorities, and guide regulatory strategy across the product lifecycle.

The role offers remote work options, a collaborative environment, and opportunities for professional growth in a fast-paced medical device sector.

Qualifications

• Bachelor's degree in a scientific/technical/healthcare field is required.
• 4+ years in regulatory affairs, specifically with medical devices.
• Experience preparing regulatory dossiers (510(k), PMA, CE Mark).

Responsibilities

• Prepare, review, and submit regulatory submissions for medical devices to SAHPRA and other authorities.
• Develop and implement regulatory strategies to support product development and market approval.
• Maintain knowledge of current medical device regulations and guidelines.
• Liaise with internal departments and external regulatory bodies.
• Manage post-market surveillance and compliance with ongoing requirements.
• Review labeling, marketing materials, and promotional claims for regulatory compliance.

Skills

Regulatory affairs

Medical devices

Dossier review/submit

Education

Bachelor's degree in a scientific/technical/healthcare field

Tools

Regulatory submissions management

Dossier preparation

Job description

Placements24 in Pretoria is seeking a detail-oriented Regulatory Affairs Specialist with medical devices expertise to join our client’s team. You will prepare regulatory dossiers, liaise with SAHPRA and other authorities, and guide regulatory strategy across the product lifecycle.

The role offers remote work options, a collaborative environment, and opportunities for professional growth in a fast-paced medical device sector.