Quality Assurance and Regulatory Affairs Specialist - Life Sciences
Comate, Belgium

Comate is looking for a motivated Quality Assurance and Regulatory Affairs (QA/RA) Specialist 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.

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 with a focus on the development of medical devices.
• 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 in 2019 as SME of the year!

Job Rewards and Benefits