Regulatory Affairs Specialist - Medical Devices

About the Role

Our client is seeking a proactive and knowledgeable Regulatory Affairs Specialist with a focus on medical devices to join their team in Pretoria. This role is crucial for ensuring that all medical devices meet the stringent regulatory requirements for market access in various regions. You will be responsible for preparing and submitting regulatory documentation, liaising with health authorities, and staying abreast of evolving regulatory landscapes. The ideal candidate will possess a strong understanding of the regulatory framework governing medical devices and demonstrate excellent attention to detail in all aspects of their work within the pharmaceutical and healthcare sector.

Key Responsibilities

• Prepare, compile, and submit regulatory submissions for medical devices to relevant health authorities (e.g., SAHPRA, FDA, EMA).
• Maintain and update product registration files and ensure ongoing compliance with applicable regulations.
• Monitor changes in regulatory requirements and assess their impact on existing products and submissions.
• Liaise with internal departments (e.g., R&D, Quality, Manufacturing) and external stakeholders to gather necessary information for submissions.
• Review product labeling, marketing materials, and claims for regulatory compliance.
• Manage post-market surveillance activities and respond to inquiries from regulatory bodies.

Requirements

• Bachelor's degree in a relevant scientific discipline (e.g., Biomedical Engineering, Pharmacy, Life Sciences).
• 3-5 years of experience in regulatory affairs , specifically with medical devices.
• Thorough understanding of global medical device regulations and submission processes.
• Experience with preparing technical documentation and regulatory dossiers.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work independently and manage multiple projects concurrently.

Benefits

• Competitive salary and regular performance reviews.
• Access to comprehensive medical and retirement benefits.
• Paid annual leave and other statutory benefits.
• Opportunities for international travel for regulatory conferences and meetings.
• A supportive work environment that encourages professional growth and development in the regulatory field.

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