QMS & Regulatory Project Manager

CONTEXT:

Could your best career choice be one that propels you toward becoming an intrapreneur or entrepreneur in your field of expertise?

Sure is that success in engineering projects often relies on key individuals demonstrating intrapreneurial leadership, i.e. who continuously develop new ideas and seek for excellence.

The best way to develop this strength is through temporary hands-on consulting roles -working alongside established intrapreneurs in international companies- to support their major expansion or improvement initiatives regarding governance, studies, or operations.

Furthermore, challenges in key strategic sectors offer greater learning opportunities with multi-million impacts:

• Public Infrastructures
• Process Manufacturing
• System & Component Technologies

One of their challenges in Governance is that without a reliable Quality Management System and strict regulatory compliance, critical industries risk severe operational shutdowns, loss of certifications, and long-term reputational damage.

=> We therefore invite you to join AETHER as a junior/medior/senior Quality & Regulatory Project Manager.

JOB DESCRIPTION:

The scope of our services is to ensure compliance, strengthen Quality Management Systems, and support operational excellence in industrial environments with high regulatory requirements.

The Key responsibilities expected from our on-site delegate might include:

As a Quality Associate Consultant:

• Participate in the implementation and monitoring of the Quality Management System under supervision.
• Contribute to regulatory watch by collecting and disseminating updates.
• Update and draft simple quality documents (SOPs, records, checklists).
• Provide administrative and operational support for the document management system.
• Prepare the documentation required for audits and inspections.
• Assist in internal and external audits, in an observer or support role.
• Follow up on the implementation of corrective and preventive actions defined by experienced profiles.
• Participate in internal training sessions and promote quality best practices.
• Provide support in the analysis of non-conformities and CAPA follow-up.

Or as a Quality Lead or Executive Consultant:

• Define, implement, and lead the Quality Management System within your scope.
• Ensure regulatory compliance and interpret complex requirements.
• Assess the impact of regulatory changes and adapt the QMS accordingly.
• Supervise and validate the drafting of critical procedures and instructions.
• Design, manage, and improve the overall document management system.
• Prepare, submit, and defend regulatory dossiers (technical files, registrations, certifications).
• Conduct and coordinate internal and external audits, including those by notified bodies and authorities.
• Act as the official contact with regulatory authorities and certification bodies.
• Guarantee a permanent state of readiness for announced or unannounced inspections.
• Train and coach teams on quality and regulatory standards.
• Define and supervise risk management systems (Business Continuity).
• Lead the continuous improvement of the QMS and advise management on strategic quality-related decisions.

The experience we are actively looking for:

• Master degree or equivalent.
• Junior: 1–4 years of experience in QMS, quality assurance, or regulatory affairs in an industrial environment. Contributes to audits, dossiers, and use of digital QMS tools.
• Senior: 5–10+ years of experience with direct responsibilities in QMS and/or regulatory affairs. Strong mastery of standards such as ISO 9001, ISO 13485, EN9100, ISO 19443, GMP, FDA, CE marking, REACH, NIS2 etc. Leads audits, independently manages regulatory dossiers, and drives digital QMS implementation.
• Fluent in French and English, Dutch is an asset depending on the site.
• An entrepreneurial experience or ambition is a plus (extra-professional or extra-academic is a great start).
• Immediate availability is preferred

• Presence in Belgium is preferred, with valid Single permit for non-EU citizens.

• Rigor, organization, and result orientation.

• Excellent written and oral communication, including with clients.
• Ability to work with project managers and multidisciplinary teams.
• Adaptability and learning mindset for juniors, autonomy for experienced profiles.
• Leadership and influence skills for senior profiles (quality reviews, client reference role).

AETHER will check if impactful opportunities are relevant for your experience or objectives.
For the sake of Business reactivity, priority is being given to candidates who are already living in Belgium and are available rapidly.

Inspire | Lead Growth | Create Impact