Regulatory Affairs Specialist - Medical Devices

Placements24; Pretoria; Hybrid; ZAR 600.000 - 900.000; Vollzeit

Benefits dieser Stelle

Competitive salary

Comprehensive benefits package

Remote work options

Professional growth opportunities

Zusammenfassung

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.

Qualifikationen

• 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).

Aufgaben

• 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.

Kenntnisse

Regulatory affairs

Medical devices

Dossier review/submit

Ausbildung

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

Tools

Regulatory submissions management

Dossier preparation

Jobbeschreibung

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.

Key Responsibilities

• 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.

Requirements

• 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.

Benefits

• 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.