The Regulatory Affairs Specialist is responsible for supporting regulatory compliance and market access for assigned medical device products. This role partners with local and global teams to execute regulatory strategies, obtain and maintain product registrations, and ensure compliance with local regulatory requirements to support successful product launches and uninterrupted supply.

Key Responsibilities

• Prepare and submit regulatory filings for new products, product changes, and linea extensions in accordance with local health authority requirements.

• Maintain product registrations, regulatory databases, and approvals for the assigned portfolio.

• Review product labeling, promotional materials, and regulatory documentation to ensure compliance.

• Collaborate with global regulatory teams to secure required documentation and align on regulatory strategies.

• Build and maintain effective relationships with health authorities, responding to inquiries and supporting regulatory discussions.

• Monitor changes in regulations, policies, and industry guidelines and assess their impact on the business.

• Partner with Marketing and cross-functional stakeholders to accelerate product approvals and launches.

• Support Special Access Scheme (SAS) and special importation requirements where applicable.

• Coordinate with supply chain, distribution, and business stakeholders to minimize regulatory-related supply disruptions.

• Support internal and external audits and contribute to continuous improvement of regulatory processes and best practices.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related field.

• Experience in Regulatory Affairs within the medical device, pharmaceutical, or healthcare industry preferred.

• Knowledge of local medical device regulations and submission processes.

• Strong communication, stakeholder management, and project coordination skills.

• Detail-oriented with the ability to manage multiple priorities in a fast-paced environment.