Regulatory Affairs Specialist

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

Job summary

Join a leading medical device company in Stellenbosch, where you will ensure compliance across the full product lifecycle. Lead regulatory submissions, contribute to audits, and support post-market surveillance. Ideal for candidates with a scientific or engineering background and regulatory experience in medical devices.

Qualifications

• Minimum of 3 years’ experience in the medical device industry necessary.
• Experience with regulatory frameworks in the medical device sector is advantageous.
• Able to maintain regulatory files and documentation.

Responsibilities

• Drive interdepartmental preparation for regulatory submissions.
• Support internal and external audits regarding compliance.
• Provide regulatory input throughout the product lifecycle.

Skills

Organisational skills

Project management

Analytical skills

Problem-solving abilities

Verbal communication

Written communication

Attention to detail

Education

Tertiary qualification in a 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 the full 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 is essential.
• 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

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.