Regulatory Affairs Specialist 3

About the role

The Regulatory Affairs Specialist 3 will drive global regulatory strategy and ensure product compliance for medical devices, focusing on high‑surveillance markets. The role supports market access, new product introductions and aligns regulatory activities with product marketing plans.

Key responsibilities

• Develop and implement global regulatory roadmaps, ensuring alignment with NPI and marketing strategies.
• Lead regulatory planning and execution across the product lifecycle, including CE marking submissions, labeling reviews and compliance protocols.
• Monitor regulatory risks, conduct risk assessments, manage compliance issues in TrackWise and drive corrective actions with cross‑functional teams.
• Collaborate with Regulatory Affairs, Quality, R&D and Marketing to support filings, certification, UDI/GTIN activities and continuous improvement of regulatory processes.

Required profile

• At least 2 years of experience in Regulatory Affairs, Quality Compliance or Product Development within the medical‑device industry.
• Bachelor’s degree (or Master’s preferred) in Biomedical Engineering, Health Sciences, Pharmaceutical, Business Administration, Law or related field.
• Fluent English communication skills.

Required skills

• Knowledge of regulatory requirements, product registrations and risk management.
• Experience with high‑surveillance markets and regulatory systems such as TrackWise.
• Familiarity with CE marking, UDI/GTIN processes and regulatory submissions.
• RAPS RAC certification is a plus.