Regulatory Affairs Specialist - Medical Devices

About the Role

Our client is seeking a detail-oriented Regulatory Affairs Specialist with expertise in medical devices to join their growing team in Pretoria . This role is essential for ensuring that all products comply with national and international medical device regulations, facilitating market access and maintaining compliance throughout the product lifecycle. You will be responsible for preparing and submitting regulatory dossiers, liaising with regulatory authorities, and providing guidance on regulatory strategies.

This is a fantastic opportunity for a regulatory professional to make a significant impact on bringing innovative medical technologies to patients.

• Prepare, review, and submit regulatory submissions for medical devices to SAHPRA and other relevant global health authorities.
• Develop and implement regulatory strategies to support product development and market approval.
• Maintain a comprehensive understanding of current medical device regulations, standards, and guidelines.
• Liaise effectively with internal departments (R&D, Quality, Marketing) and external regulatory bodies.
• Manage post-market surveillance activities and ensure compliance with ongoing regulatory requirements.
• Review product labeling, marketing materials, and promotional claims for regulatory compliance.

• Bachelor's degree in a scientific, technical, or healthcare-related field.
• Minimum of 4 years of experience in regulatory affairs , specifically with medical devices.
• Proven experience in preparing and submitting regulatory dossiers (e.g., 510(k), PMA, CE Mark).
• Solid knowledge of relevant medical device regulations (e.g., MDR, FDA regulations, SAHPRA requirements).
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently and manage multiple projects simultaneously.

• Competitive salary and potential for annual bonuses.
• Comprehensive benefits package including medical, retirement, and life insurance.
• Flexible work arrangements with remote work options available.
• Opportunities for professional growth and advanced regulatory training.
• A stimulating and collaborative work environment in Pretoria .
• Support for continuing education and professional certifications.