Remote QMS & Regulatory Lead - Europe (ISO 9001/13485)

Das ist der Job

Primary countries supported: France, Belgium, Luxembourg, Italy, Spain, and Portugal.

Darum lohnt es sich

Quality & Regulatory Management Representative Position Summary As part of the European Quality & Regulatory team, this role supports commercial activities within the Specialty Diagnostics Group (SDG), including sales and marketing, distribution, importation, warehousing, customer service, and field service operations.

Key Responsibilities • Ensure the effective implementation, monitoring, and maintenance of the TFD Quality Management System (QMS) across assigned European regions. • Maintain compliance with ISO 9001 and ISO 13485 certification requirements and support QMS deployment activities. • Plan and execute regional Management Reviews and monitor overall QMS performance. • Manage quality processes, including NCRs, CAPAs, and audit observations, ensuring timely resolution. • Lead and coordinate internal and external audit activities, including preparation, execution, and follow-up. • Collaborate with local site teams, business partners, customers, suppliers, distributors, and regulatory stakeholders on quality and compliance topics. • Support complaint management processes and ensure appropriate follow-up within the region. • Drive Extended Producer Responsibility (EPR) activities and support product legislative compliance initiatives (e.g., WEEE, battery directive, PPWR). • Support quality training activities and mentor employees involved in quality processes. • Partner with Thermo Fisher Scientific teams to drive continuous improvement and harmonization of quality practices.

Requirements & Qualifications • Degree in Engineering, Biological Sciences, Chemistry, Biochemistry, or equivalent preferred. • Proven experience working with Quality Management Systems in regulated environments. • Strong knowledge of ISO 9001 and ISO 13485 standards. • Experience with GxP and quality compliance requirements. • Confirmed internal auditing experience (ISO 9001 required; ISO 13485 preferred). • Experience with product legislative compliance (PLC) is a plus. • Strong communication and stakeholder management skills, with the ability to influence teams across different functions and countries. • Ability to work independently and manage priorities effectively in a remote environment. • Customer-focused mindset with an understanding of commercial processes. • Fluent professional communication skills in French and English (written and spoken). • Willingness to travel occasionally within Europe for audits and site visits. • Start Date: ASAP • Duration: 10 months • Location: Remote (with occasional travel within Europe) The position ensures that the TFD Quality Management System remains effective, compliant with ISO 9001 and ISO 13485 standards, and aligned with applicable regulatory requirements across assigned European regions.