Вакансія: Quality Engineer Regulatory Affairs Teams

Our client, an international innovation IT product company with offices in 18 countries, is looking for candidates to fill in the position  Quality Engineer Regulatory Affairs Teams

Work place: Kyiv, Ukraine

RESPONSIBILITIES

• Further build global Quality Management System for Regulatory Affairs team in line with MDSAP – Medical Device Single Audit Program (international), MDR – Medical Device Regulation (Europe), i.e. global regulatory framework, (ISO) standards.
• e.g. Will maintain the SOPs that are used for assessment of the change, maintenance of technical documentation, release of products.
•  Act as the product owner for the SharePoint online portals for the global regulatory affairs team and manage projects related to these portals.
•  Align with Quality manager of HQ and global Quality and Regulatory Manager regarding quality objectives and quality initiatives.

REQUIREMENTS

• Experience in quality operations in a regulated environment, such as a medical device, pharmaceutical, automotive/aviation company, etc.
• Broad interest in different domains of the lifecycle of a medical device (interest for the fields of team members in order to provide regulatory support to new device development, change in services/production environment, formulate requirements that will be added to the template).
• Affinity with end-to-end process view thinking / systematic approach – all activities of this expert need to be focused on RA specialists and labeling team members working in a more and more systematic way.
• Affinity with writing documentation, such as SOPs (processes) in English. Therefore, fluency in English – written and spoken.
• Communication experience with stakeholders in a global matrix structure.

Motivation to join our team

Compensation: we would like to know you salary expectation that would make you change the jobs

Possibility to work in a big (2000+ people worldwide, 400 in Ukraine) and successful company (30+ years, stocks publically traded)

Career growth. It means the opportunity to take other role, to change department, city, country as the company has offices in 18 countries

Unique working environment with a variety of knowledge sharing opportunities

We are waiting for Your CV:  escadra@old.escadra.com.ua