Quality and Regulatory Affairs (QA/RA) Consultant

Key Responsibilities:

• Support clients in both the private and public sectors, ensuring adherence to regulatory standards and guidelines.

• Provide expertise in quality management systems, risk management, process validation, and audits at client sites or third-party audits.

• Assist in the development and implementation of regulatory strategies tailored to the specific needs of clients in the medical device and healthcare industry.

• Collaborate with cross-functional teams to ensure compliance with ISO standards, FDA regulations, and other international requirements.

• Guide clients through the regulatory approval process, including CE marking, technical documentation, and international registration applications.

• Conduct gap analyses, quality/regulatory training, and ongoing compliance support to facilitate successful product development and market access.

• Stay abreast of industry trends, regulatory updates, and best practices to provide strategic guidance and innovative solutions to clients.

Qualifications and Skills:

• Minimum of 2 years of experience in quality management and/or regulatory affairs within the medical device or healthcare sector.

• Bachelor's or Master's degree in engineering, biology, chemistry, pharmaceuticals, or an equivalent scientific qualification, or relevant work experience.

• Proficiency in English, as well as Dutch and/or French both spoken and written.

• Strong understanding of regulatory requirements, including MDD/MDR, IVDD/IVDR, ISO 13485, ISO 14971, and other relevant standards.

• Experience in conducting audits, managing quality management systems, and facilitating regulatory submissions.

• Excellent communication, organizational, and problem-solving skills.

• Ability to work independently, yet thrive in a collaborative team environment.

• Passion for healthcare, technology, and innovation.