As we continue to grow, we are looking for a driven professional to join our Quality Management System team as a
Homologation Specialist / QMS Specialist (Homologation & Regulatory Affairs) .
Your Key Responsibilities
Supporting New Product Introduction (NPI) from a regulatory perspective.
Assessing the regulatory impact of design and process changes.
Participating in risk management activities in accordance with
ISO 14971 .
Creating, updating, and maintaining Technical Files for Medical Devices.
Preparing and maintaining regulatory documentation in compliance with
MDR 2017/745
and local requirements, including Declarations of Conformity.
Coordinating and supporting homologation and market approval processes for medical devices across EU and global markets.
Managing product registrations in EU and non-EU markets and cooperating with distributors and local partners to adapt documentation to local requirements.
Supporting reimbursement processes (e.g., the German market and others) and preparing related documentation.
Monitoring regulatory, normative, and reimbursement requirements, and cooperating with Notified Bodies and regulatory authorities.
Supporting internal and external audits within the regulatory and homologation domain.
Supporting post-market surveillance (PMS) activities and the medical incident management process (vigilance, MIR reports, cooperation with authorities like BfArM or Fimea).
Cooperating closely with suppliers, R&D, production, sales, and other cross-functional teams.
Requirements
Higher education (preferably in engineering, medical, quality-related, or a related field).
Sound knowledge of
MDR 2017/745
and relevant regulatory requirements.
Proven experience in medical device registration and international homologation processes.
Familiarity with standards:
ISO 13485
and
ISO 14971 .
Knowledge of Technical Files structure and quality tools (8D, FMEA, 5 Why).
Advanced English
proficiency (required); additional languages (e.g., German) will be an asset.
Project-oriented mindset (NPI) combined with strong analytical and organizational skills.
Ability to work independently and collaborate effectively in an international, cross-functional environment.
What We Offer
Stable employment with salary adequate to competencies and experience.
Private medical care (Medicover), Multisport, preferential life insurance, co-funded lunches.
Great development opportunities within global working environment.
Excellent working atmosphere.
Flexible timework.
Many experts you can learn from.
Open and accessible management team.
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Homologation Specialist in Łódź – pracodawca: Rehasense Group
Rehasense to doskonały pracodawca, który oferuje stabilne zatrudnienie oraz atrakcyjne wynagrodzenie dostosowane do kompetencji i doświadczenia. Pracując w Piotrkowie Trybunalskim, będziesz częścią dynamicznego zespołu w międzynarodowej organizacji, która stawia na rozwój pracowników, oferując liczne możliwości awansu w globalnym środowisku. Dodatkowo, firma zapewnia bogaty pakiet benefitów, w tym prywatną opiekę medyczną, kartę Multisport oraz preferencyjne ubezpieczenie na życie, co czyni ją wyjątkowym miejscem pracy dla ambitnych profesjonalistów.
