Regulatory Affairs Consultant

Mantell Associates; München; Vor Ort; EUR 100.000 - 125.000; Vollzeit

Zusammenfassung

A leading recruitment firm is seeking a seasoned Regulatory Affairs Consultant in Munich to lead regulatory strategies for Class III medical devices. The role requires proven experience in regulatory submissions and outstanding technical writing skills. The consultant will collaborate with multidisciplinary teams and act as the main liaison with regulatory authorities, ensuring compliance and documentation integrity in a fast-paced environment.

Qualifikationen

• Proven experience in Regulatory Affairs leadership for Class III medical devices.
• Exceptional technical writing and documentation skills.
• Deep expertise in EU MDR and ISO 13485 standards.

Aufgaben

• Lead regulatory strategy for Class III medical device registrations within the EU.
• Act as primary regulatory liaison with Notified Bodies and regulatory authorities.
• Support inspection readiness and manage regulatory queries.

Kenntnisse

Regulatory Affairs

Technical Writing

Collaboration

Stakeholder Management

Jobbeschreibung

Mantell Associates is partnered with an innovative Medical Device company in Munich, who is seeking a seasoned Regulatory Affairs Consultant on a contract basis to provide expert oversight and strategic support for Class III device registration and regulatory compliance.

This on-site role demands specialised regulatory experience and will contribute directly to advancing patient safety and market readiness.

Regulatory Affairs Consultant - Responsibilities

• Lead comprehensive regulatory strategy and activities for Class III medical device registrations within the EU - including MDR pathway management, clinical evaluation, TÜV interfacing, and technical documentation
• Prepare, review, and author key regulatory submissions and modules (including STED/CTD, CERs, risk management compliance, post-market planning)
• Act as the primary regulatory liaison with Notified Bodies, regulatory authorities, and internal stakeholders (Engineering, Quality, Clinical, and R&D)
• Support inspection readiness, manage regulatory queries, and ensure documentation integrity throughout the product lifecycle
• Monitor evolving regulatory frameworks, industry guidance, and harmonisation efforts relevant to high-risk medical devices, providing strategic insights to guide compliance planning

Regulatory Affairs Consultant - Requirements:

• Proven experience in Regulatory Affairs leadership for Class III medical devices, including MDR submissions and Notified Body interactions
• Deep expertise in regulatory standards: EU MDR, ISO 13485, MEDDEV, and risk management frameworks (ISO 14971)
• Exceptional technical writing and documentation skills with capacity to manage high-quality regulatory content under tight timelines
• Strong collaboration abilities and stakeholder management across multidisciplinary teams - ensuring regulatory insights support product and business decisions
• Based in or willing to relocate to Munich, Germany, with legal permission to work on-site full time

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at [phone].