Remote Senior Regulatory Affairs Lead – Devices & Pharma

Placements24; LegKraal Gate; Hybride; ZAR 1 990 000 - 2 985 000; Plein temps

Avantages offerts par ce poste

Health insurance

Home office allowance

Remote work flexibility

Competitive salary + bonus

Résumé du poste

Placements24 is seeking a highly experienced Senior Regulatory Affairs Specialist to join our expanding operations in a fully remote capacity, focusing on medical devices and pharmaceuticals.

You will lead regulatory strategies, prepare and submit dossiers, liaise with health authorities, and guide cross-functional teams to ensure global market entry and lifecycle management across global markets.

Qualifications

• Bachelor's or Master's degree in a relevant scientific, technical, or healthcare field.
• 6+ years in regulatory affairs with medical devices and pharmaceuticals.
• Proven track record of successful submissions and approvals with major regulatory bodies.
• In-depth knowledge of US FDA and EU MDR/IVDR regulations.
• Demonstrated ability to work independently and manage projects in a remote environment.

Responsabilités

• Develop and implement regulatory strategies for new product development and lifecycle management.
• Prepare, review, and submit regulatory applications (e.g., PMA, 510(k), NDAs) to relevant health authorities worldwide.
• Maintain regulatory compliance with applicable laws, regulations, and guidelines (FDA, EMA, etc.).
• Liaise effectively with regulatory agencies, responding to inquiries and facilitating communication.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, and Marketing.
• Monitor changes in the regulatory environment and assess their impact on the company.

Connaissances

Regulatory affairs

US FDA knowledge

EU MDR/IVDR knowledge

Project management

Formation

Bachelor's or Master's degree in a relevant field

Description du poste

Placements24 is seeking a highly experienced Senior Regulatory Affairs Specialist to join our expanding operations in a fully remote capacity, focusing on medical devices and pharmaceuticals.

You will lead regulatory strategies, prepare and submit dossiers, liaise with health authorities, and guide cross-functional teams to ensure global market entry and lifecycle management across global markets.