Senior RA Specialist

Liposphere is hiring a Senior RA Specialist

Liposphere develops innovative Class III implantable medical devices and is advancing towards global commercialization.

Position Overview

The Senior RA Specialist is responsible for managing post-approval regulatory activities, including device registrations and maintenance of market access for Class III implantable medical devices across multiple territories.

The role focuses on ensuring that, following primary regulatory approval (e.g. CE marking), the products are properly registered, maintained, and compliant in each target market (e.g. Germany, Italy, and other EU/international countries).

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Key Responsibilities

Market Registration & Market Access

• Lead and execute national registrations of approved devices in EU countries (e.g. Germany, Italy, France, Spain) and other international markets.
• Prepare and submit registration dossiers to competent authorities and manage related correspondence.
• Ensure timely product listing in national databases. (e.g. EUDAMED, where applicable, and local systems).

Regulatory Lifecycle Management

• Maintain existing registrations and approvals across all territories.
• Manage updates, renewals, notifications, and variations as required by local regulations.
• Track regulatory commitments and ensure ongoing compliance post-approval.

Regulatory Assessment & Change Management

• Perform regulatory impact assessments for:
• Design changes
• Manufacturing/process changes
• Labelling/IFU updates
• Supplier changes
• Define required regulatory actions per territory (notification, submission, or no action).

Cross-functional Support

• Work closely with QA, Clinical, and Operations to ensure regulatory compliance during changes and lifecycle activities.
• Provide regulatory guidance for labelling and market-specific requirements.

Requirements

•  Bachelor’s degree in Life Sciences, Engineering, Laws, or related field- an advantage.
• Minimum 4–5 years of Regulatory Affairs experience in medical devices.
•  Mandatory: experience with Class III implantable medical devices.
•  Hands-on experience with:
• EU MDR post-approval activities
• Device registration in EU countries (national level)
• Regulatory impact assessments / change control
• Experience working with competent authorities and regulatory databases.
• Excellent attention to detail and organisational skills.