Regulatory Affairs Specialist ensures timely registration and marketing authorization of company products in order to expand the product range as fast as possible and thereby increase sales.
Main Tasks and Responsibilities:
Proactively submit all necessary registration documents for new products to authorities, ensuring a smooth and timely approval process that propels our innovations to market swiftly and efficiently.
Maintain our product’s market presence by ensuring all registration renewals are submitted promptly and monitored meticulously, securing regulatory approval without delays.
Stay ahead of the curve by ensuring timely submissions and approvals for all upcoming product variations, allowing us to adapt and thrive in a dynamic market.
Keep our Product Registration Database up-to-date and provide senior staff with the latest registration statuses, facilitating informed decision-making and strategic planning.
Stay informed on competitors' registration statuses, using this intelligence to refine our strategies and maintain a competitive edge.
Collaborate with business partners to navigate and resolve certification challenges, fostering strong relationships and ensuring seamless certification processes.
Keep the first-line manager updated of the latest regulatory legislation changes and updates from regulatory authorities, ensuring our compliance and strategic alignment with industry standards.
Monitor adverse events for medical devices
Professional and General Requirements
Higher medical education (diploma in medicine, pharmacy or other health related disciplines).
Strong communication skills.
Strong persuading and influencing skills.
High personal initiative and achievement motivation.
At least 3 years experience in medical device registration function either in a medical device company or registration body
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