Regulatory Affairs - Manager

Responsibilities

• Identify regulatory requirements and stay up to date with the evolving regulatory landscape in each marketing territory.
• Serve as the company representative and committee member in local medical device industry associations (e.g., MMDA).
• Initiate, validate, review, plan, and strategize to ensure all products remain compliant with applicable statutory and regulatory requirements.
• Communicate regulatory updates to relevant internal stakeholders to ensure alignment across departments.
• Plan and drive process improvements, including the digitalization of Regulatory Affairs (RA) workflows.
• Oversee and maintain Medical Device Establishment/Dealer Licenses with the relevant authorities.
• Supervise pre-market regulatory activities including medical device registration, change notifications, and applications for special authorizations or exemptions with government bodies.
• Manage post-marke...