Regulatory Affairs Specialist

Pillango Placements; Stellenbosch; On-site; ZAR 200,000 - 300,000; Full time

Job summary

A leading medical device company in Stellenbosch is seeking a compliance expert to lead regulatory submission preparations and audits. This role requires a scientific or engineering background with at least 3 years in the medical device sector. The ideal candidate will have detailed knowledge of ISO standards and FDA regulations, alongside strong project management, organizational, and communication skills.

Qualifications

• Minimum of 3 years’ experience in the medical device industry.
• Proven experience with ISO 13485, EU MDR, and FDA requirements.

Responsibilities

• Drive interdepartmental preparation for regulatory submissions.
• Support internal and external audits.
• Maintain regulatory files and documentation.

Skills

Organisational skills

Project management

Analytical skills

Problem-solving

Communication skills

Education

Tertiary qualification in science, engineering, or biological field

Tools

ISO 13485 Quality Management System

EU MDR 2017 / 745 Technical Documentation

FDA 510(k) submissions

Job description

Join a leading, values-driven medical device company in Stellenbosch and play a key role in ensuring compliance across the full product lifecycle. This position offers the opportunity to lead regulatory submission preparations, contribute to audits, and provide strategic input from development through to post-market surveillance. Ideal for candidates with a scientific or engineering background and solid experience in medical device regulatory frameworks.

Key Responsibilities

• Drive interdepartmental preparation for regulatory submissions.
• Maintain up-to-date knowledge of applicable regulatory requirements.
• Support internal and external audits.
• Provide regulatory input for product development and thefull product lifecycle.
• Maintain regulatory files and documentation.
• Support post-market surveillance and vigilance reporting.

Qualifications and Experience

• A tertiary qualification in a science, engineering or biological field isessential.
• Minimum of 3 years’ experience in the medical device industry.
• Proven experience with any of the following will be advantageous :
• ISO 13485 Quality Management System
• EU MDR 2017 / 745 Technical Documentation and conformity assessment
• FDA 510(k) submissions and US FDA requirements

Skills and Competencies

• Excellent organisational and project management skills
• Task driven
• Detail-oriented with strong analytical and problem-solving abilities
• Clear and effective verbal and written communication skills
• Ability to work independently and in cross-functional teams

NOTE : We ONLY accept online applications. We do not consider direct applications via Whatsapp or email.

The proposed salary bracket for the position is R30k - R40k, but note that the employer retains the right to provide a remuneration package that aligns with industry norms and the specific qualifications, skills and experience of the selected candidate.

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