Regional Regulatory Affairs Manager

• Manage product lifecycle activities (registration, changes and renewal) across all countries in Asia
• Assess regulatory impact of change controls proposed by Corporate
• Prepare submission dossier based on documentation provided by RA Corporate according to local requirements
• Ensure the follow-up of the registration procedure
• Liaise with local distributors or local regulatory third parts for these activities
• Ensure traceability by providing the RA Corporate with local submitted regulatory dossiers
• Maintain up-to-date knowledge of country-specific regulatory requirements related the countries in Asia in collaboration with local distributors or local regulatory third parts and communicate regulatory changes to RA Corporate
• Assist in audits and inspections by Competent Authorities
• Validate promotional material related to Teoxane’s subsidiary and or distributors as required
• Support post-market surveillance activities

• Scientific or pharmaceutical background (master’s degree or equivalent)
• At least 7-10 years of experience in RA within MedTech sector, with experience in medical devices/ medical aesthetics preferred
• Strong knowledge of local medical device regulations and competent authorities related to all Asian countries
• Ability to solve complex issues with distributors or competent authorities
• Proficiency in international standards (MDR, ISO13485, ISO 14971, GHTF, IMDRF)
• Experience in preparing and managing regulatory submissions
• Ability to interpret and apply regulatory requirements to products
• Intercultural communication: ability to collaborate with multicultural teams
• Project management: tracking deadlines in dashboard, coordinating stakeholders, reporting to RA Corporate
• Regulatory intelligence: proactive monitoring of regulatory changes in the assigned Region
• Technical documentation: accuracy in file management, traceability and compliance
• Proficient in English
• Local language a plus

Local language a plus