Regulatory Affairs Specialist

Maltron International Ltd; Rayleigh; On-site; GBP 30,000 - 50,000; Part time

Job summary

A leading UK-based manufacturer of medical devices seeks a meticulous Regulatory Affairs Specialist. This part-time role involves ensuring compliance with UKCA, EU MDR, and international regulations. The ideal candidate will have a proven background in regulatory affairs, managing submissions, and maintaining technical documentation, contributing to the safe delivery of life-changing devices to patients worldwide.

Benefits

Flexibility

Growth opportunities

Qualifications

• Proven background in medical device regulatory affairs.
• Experience in EUDAMED, UDI/GS1 barcoding, and technical file maintenance.
• Familiarity with ISO 13485, MDR Annex XIV, and PMS requirements.

Responsibilities

• Ensure all products comply with UK, EU, and international regulations.
• Manage EUDAMED registrations and handle UK MHRA submissions.
• Coordinate GS1 GTIN/barcode creation and ensure compliance.

Skills

Regulatory Compliance

Detail-oriented

Technical Documentation

Tools

EUDAMED

GS1 barcoding

ISO 13485

Job description

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Direct message the job poster from Maltron International Ltd

Operations Director at Maltron International Ltd

We are a leading UK-based manufacturer of innovative body composition and fluid assessment medical devices, with a growing presence in the UK, EU, Far East, and Middle East. Committed to quality and compliance, we’re looking for a meticulous Regulatory Affairs Specialist to ensure our products meet all regional requirements and market standards.

As our Part-Time Regulatory Affairs Specialist, you’ll be the cornerstone of our compliance efforts, ensuring adherence to UKCA, EU MDR, and international regulations across all markets. You’ll manage submissions, registrations, and labelling, while keeping pace with evolving regulatory landscapes.

Key Responsibilities:

1. Regulatory Compliance:

• Ensure all products comply with UK, EU, and international regulations.
• Maintain up-to-date knowledge of regulatory changes and implement necessary updates.
• Oversee technical documentation.

EUDAMED & Submissions:

• Manage EUDAMED registrations.
• Handle UK MHRA and EU Notified Body submissions, including renewals and variations.

Product Labelling & UDI:

• Coordinate GS1 GTIN/barcode creation and ensure compliance.
• Review and approve labelling, IFUs, and marketing materials for regulatory accuracy.

International Markets:

• Support registrations in global markets.

Quality & Post-Market:

• Assist with audits (internal/external) and regulatory inspections.
• Monitor Field Safety Notices (FSNs) and manage incident reporting (e.g., MHRA, EUDAMED).

Who You Are:

Experience: Proven background in medical device regulatory affairs.

Technical Skills:

• Experience in EUDAMED, UDI/GS1 barcoding, and technical file maintenance.
• Familiarity with ISO 13485, MDR Annex XIV, and PMS requirements.
• Detail-oriented: Ability to interpret regulations and implement compliant solutions.

Why Join?

• Impact: Ensure life-changing devices reach patients worldwide, safely and compliantly.
• Flexibility: Part-time role.
• Growth: Work with cutting-edge medical tech and diverse markets.

Seniority level

• Entry level

Employment type

• Part-time

Job function

• Legal

Industries

• Medical Device