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:
* 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.
Additional Details:
* Seniority level: Entry level
* Employment type: Part-time
* Job function: Legal
* Industries: Medical Device
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