Regulatory Affairs Manager

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Approach People Recruitment. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and standards for medical devices.

• Regulatory Affairs Management: Manage the Regulatory Affairs team and coordinate activities to ensure compliance with regulatory requirements.
• Regulatory Monitoring: Ensure regulatory and normative monitoring of products distributed in Europe and internationally, identify applicable standards and regulations, and coordinate monitoring activities with other functions within the company.
• CE Marking: Manage CE Marking files, draft technical files, and make market placement declarations, ensure the technical file is kept up to date, and drive the regulatory evaluation process of changes and their communication to the notified body/competent authorities.
• Regulatory Representation: Act as regulatory representative in the design process, propose and implement suitable technical and regulatory strategies, manage the list of standards applied per product range, and provide regulatory support throughout the Design process.
• Export Registrations: Manage export registrations, draft regulatory registrations, coordinate with international counterparts, handle regulatory and technical queries from health authorities, ensure license tracking and maintenance, and manage dossier variations with international counterparts.

• Education: Master's degree in a scientific field.
• Experience: At least 10 years' experience in a Regulatory Affairs department within the medical device (class III or IIb) or pharmaceutical industry.
• Skills: Proven experience in Management, mastery of standards and regulations applicable to medical devices (ISO 13485; Directive 93/42 EEC, MDR 2017/745,...), fluent English, and proficiency in computer tools (office applications).
• Personal Qualities: Analytical and synthesis skills, discretion, objectivity, organizational skills, interpersonal and writing abilities.