Regulatory Affairs Manager - Medical Devices

Placements24; Mossel Bay; Hybrid; ZAR 1,000,000 - 1,800,000; Full time

Job summary

Placements24 is seeking a highly experienced Regulatory Affairs Manager for a fully remote role within South Africa. You will lead regulatory strategies for medical devices across SAHPRA, FDA, and CE markets.

The position requires strong leadership, excellent communication, and the ability to manage multiple complex projects from a remote setting. A dynamic team awaits those who can drive compliance and timely market access.

Qualifications

• Bachelor’s degree in a scientific or technical field; Master’s preferred.
• Minimum 7 years in regulatory affairs for medical devices.
• Proven track record with submissions/approvals in SAHPRA, FDA, and EU CE marking.
• Strong leadership, communication and project management skills.

Responsibilities

• Develop and execute global regulatory strategies for medical devices.
• Prepare and manage regulatory filings and dossiers for SA, US, and EU markets.
• Ensure compliance with MDR/IVDR, FDA QSR and ISO 13485.
• Liaise with regulatory authorities and respond to inquiries.
• Lead and mentor a remote team of regulatory professionals.
• Monitor regulatory changes and assess impact on products.

Skills

Regulatory strategy

Leadership

Regulatory submissions

Communication

Remote team management

Quality management systems

Regulatory information management

Education

Bachelor’s degree in a scientific/engineering/technical field

Master’s degree or higher

Tools

Regulatory information management systems

Job description

About the Role Our client, a leading innovator in the medical device industry, is seeking a highly experienced Regulatory Affairs Manager to join their expanding global team. This is a fully remote position, allowing you to contribute to groundbreaking work from anywhere within South Africa. You will be responsible for developing and implementing regulatory strategies to ensure compliance with international regulations for medical devices, including those from SAHPRA, FDA, and CE marking. The ideal candidate will possess a deep understanding of the medical device landscape, a proven track record in obtaining regulatory approvals, and excellent communication and leadership skills. This role is critical for bringing innovative medical technologies to market swiftly and safely.

Key Responsibilities

• Develop and execute global regulatory strategies for new and existing medical devices.
• Prepare, submit, and maintain regulatory filings and dossiers for various markets (e.g., South Africa, USA, Europe).
• Ensure compliance with applicable regulations and standards, including ISO 13485, MDR, IVDR, and FDA 510(k)/PMA requirements.
• Act as a liaison with regulatory authorities, responding to inquiries and managing inspections.
• Provide regulatory guidance and support to R&D, product development, quality assurance, and marketing teams.
• Conduct regulatory assessments of product changes and new product developments.
• Develop and implement departmental SOPs and ensure team adherence to regulatory processes.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
• Manage post-market surveillance activities and ensure compliance with reporting requirements.
• Lead and mentor a remote team of regulatory affairs professionals.

Requirements

• Bachelor's degree in a scientific, engineering, or technical field. A Master's degree or higher is preferred.
• Minimum of 7 years of experience in regulatory affairs within the medical device industry.
• Proven experience with regulatory submissions and approvals in key markets (South Africa, US FDA, EU CE Mark).
• In-depth knowledge of medical device regulations (MDR, IVDR, FDA QSR, SOR).
• Experience with ISO 13485 quality management systems.
• Excellent written and verbal communication skills, with strong presentation abilities.
• Demonstrated leadership and project management skills.
• Ability to work independently and manage multiple complex projects in a remote environment.
• Proficiency in regulatory information management systems is a plus.
• Must be legally eligible to work in South Africa and comfortable working remotely.

Benefits

• This position offers a competitive salary and comprehensive benefits package, commensurate with experience.
• Enjoy the flexibility and autonomy of a fully remote role, allowing for excellent work-life integration.
• Be part of a company that is at the forefront of medical technology innovation.
• Opportunities for professional development and career advancement are abundant.
• Contribute to improving global health outcomes by ensuring access to safe and effective medical devices.
• This is a fantastic opportunity for a seasoned regulatory professional to lead and make a significant impact from anywhere in South Africa.