Quality and Regulatory Affairs Manager - En remoto, España - Luka Global Group

Luka Global Group

Empresa verificada

En remoto, España

hace 2 semanas

Publicado por:

Isabel García

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Descripción

Job Information:

Industry

Digital Health

Remote Job

This is a remote position.

A Quality and Regulatory Affairs Manager is sought to join an expanding Digital Health Start-Up. If you are passionate about world-class MedTech products, solving real-world problems and making a difference in patients' lives this could be the role for you

The role can be based in Munich or on a fully remote basis within Europe.

Key responsibilities:

Support QMR in the maintenance and improvement of the QMS to continuously meet requirements from ISO 13485 and Regulation (EU) 2017/745 (MDR)
Regulatory Compliance: Stay up to date with medical device regulations and standards and ensure the company's adherence to evolving requirements in AI powered SaMD
Internal and

External Audits:
Support in planning and conducting internal audits to assess the effectiveness of the QMS. Support external audits from notified bodies and regulatory bodies.

Process Improvement: Identify opportunities for process optimization and drive continuous improvement initiatives to enhance product quality and operational efficiency
Risk Management: Collaborate with crossfunctional teams to integrate risk management activities into product development and postmarket processes
Document Control: Oversee document control procedures, including the creation, review, and maintenance of quality documents and records
Training and Education: Provide training to employees on quality procedures, regulations, and best practices
Non-Conformance and

CAPA:
Manage non-conformance events and lead corrective and preventive action (CAPA) processes to address quality issues effectively

Supplier Quality Management: Work with the purchasing team to evaluate and monitor suppliers to maintain a robust supply chain.

Requirements:

Bachelor's degree (or equivalent) in a relevant scientific or engineering discipline
Handson experience in Quality Management Systems and ISO 13485 within the medical device industry
Familiarity with digital health technologies, software development life cycle (SDLC), and cybersecurity in medical devices is advantageous
Basic understanding of medical device regulations and standards
Excellent communication skills to interact effectively with various stakeholders
Fluent in German and English

Benefits:

The role offers a competitive salary and most importantly the chance to be a central player in the future of healthcare.