Quality Assurance and Regulatory Affairs (QA/RA) manager

16/09/20

Location

Karel van lotharingenstraat 4 Leuven Belgium

Function type

Quality Assurance and Regulatory Affairs (QA/RA) manager

Vacancy

Comate is looking for a motivated Quality Assurance and Regulatory Affairs (QA/RA) manager to support its growth and expansion in the Life Sciences sector.

The aim of our passionate team is to cooperate with our clients in order to develop a unique product that is more innovative and more advanced than anything that is currently available on the market.

As Comate’s QA/RA manager you are responsible for maintaining and improving our Quality Management System, in addition to promoting quality and continual improvement within the company. You also support the Life Sciences customer projects by providing expert regulatory and quality input to the team of engineers and designers working on these projects.You will:

  • Ensure that the Quality Management System requirements are effectively established and in accordance with applicable medical device regulations for Comate’s Life Sciences related activities.

  • Support engineering and product development projects for Life Sciences customers by providing expert input and know-how to the team of engineers and designers, and support the writing of the technical files and related documentation.

  • Conduct internal audits and provide guidance regarding best practices and continuous improvement.

  • Support core quality systems including root cause analysis, CAPA, non conformance, chance control, and risk management, as well as control of documentation and records.

  • Coordinate external audits from notified bodies and customers. Follow up on any actions resulting from these audits.

  • Maintain expert current knowledge of European and foreign regulations, legislations, best practices and guidelines related to QA/RA, monitor changes to applicable laws and regulations, identify impact to the business, and in collaboration with other stakeholders, develop response strategies.

  • Manage key quality and regulatory affairs initiatives to drive continuous improvement.

  • Other duties as assigned.

Requirements

You have:

  • A Master’s or a Bachelor’s degree in engineering, technical or science field.

  • A minimum of 5 years of work experience in a quality assurance and/or regulatory affairs role in a Life Sciences environment.

  • In depth understanding of a Quality Management System, and requirements for ISO 13485, MDR and other relevant regulations.

  • Thorough understanding of quality assurance concepts and practices.

  • Ability to interpret and apply regulations and compliance concepts.

  • Experience in regulatory submissions, registrations and other product approval documentation.

  • Excellent communication skills, written and verbal. Excellent written and spoken English, additional languages are considered a plus.

  • Computer literate (MS Office)

  • Strong organisational and presentation skills, as well as the ability to multi-task and work well under pressure.

  • Detail oriented, team player

Benefits

  • You will be joining a team of enthusiastic and passionate colleagues.

  • You will be working on the design en development of truly unique products and solutions, end-to-end!

  • Comate offers a broad portfolio of training and educational courses, allowing you to grow.

  • Comate is a fast growing company, so you can grow with us and grow in your area of expertise or interest.

  • You will be able to work in a nice office right in the heart of the vibrant city of Leuven

  • You will get an attractive salary package with a lot of extra benefits

  • And yes, Comate was elected SME of the year! 

Interested?

Apply via our platform.

Job application