RA/QA Specialist

Nuwhï; Antwerpen; On-site; EUR 70,000 - 100,000; Full time

Job summary

Nuwhï bv in the Antwerp region is seeking a QA/RA Specialist to strengthen the quality and regulatory framework for medical devices. You will work with the existing QA team to ensure products, processes and documentation meet ISO 13485 standards and EU MDR requirements.

This role offers growth toward broader leadership responsibilities, with exposure to audits, regulatory filings, and collaboration with manufacturing partners across Europe.

Qualifications

• 4–8 years in Quality Assurance and/or Regulatory Affairs in the medical device industry.
• Practical knowledge of ISO 13485 and EU MDR.
• Experience with Quality Management Systems, audits and regulatory documentation.
• Hands-on, structured and solution-oriented approach.
• Ability to work independently and take ownership.
• Strong communication and collaboration skills.
• Fluency in English; Dutch is an advantage.

Responsibilities

• Maintain and further develop the Quality Management System (ISO 13485).
• Support ongoing compliance with EU MDR.
• Manage and update technical and regulatory documentation.
• Prepare for and participate in internal and external audits, with corrective actions.
• Coordinate with external manufacturing and sterilisation partners on QA.
• Contribute to quality control, release processes and continuous improvement.
• Collaborate with stakeholders to embed quality and regulatory requirements in daily operations.
• Support new product developments from a QA/RA perspective.
• Take increasing ownership of QA/RA projects as experience grows.

Skills

Quality Assurance

Regulatory Affairs

ISO 13485

EU MDR

Quality Management System

Audits

Regulatory documentation

PRRC

Job description

Ready to take ownership and grow into a broader QA/RA leadership role?

Location: Antwerp Province, Belgium | Medical Devices | Permanent Position

Are you an experienced QA/RA professional looking for more than a traditional specialist role?

Would you like to work in an environment where your expertise genuinely matters, your ideas are heard, and you have the opportunity to grow into a broader leadership position?

For our client, a fast-growing and innovative medical device company based in the Antwerp region, we are looking for a QA/RA Specialist who combines solid technical expertise with a pragmatic mindset, strong interpersonal skills and the ambition to take on increasing responsibility.

This is an opportunity to join a dynamic, entrepreneurial organisation where Quality & Regulatory Affairs are closely connected to the entire business, and where your contribution will have a direct and visible impact.

About the company

Our client develops innovative medical devices and solutions that support healthcare professionals in surgical environments, with a particular focus on orthopaedic procedures.

With an established international presence and ambitious growth plans, the company is entering an exciting new phase of development.

As part of a relatively small and collaborative team, you will benefit from short decision-making lines, direct access to colleagues across different functions and the opportunity to contribute well beyond the boundaries of a traditional QA/RA position.

Your role

As QA/RA Specialist, you will play an important role in maintaining and further developing the company's quality and regulatory framework.

Working closely with the existing QA expertise and other colleagues across the organisation, you will help ensure that products, processes and documentation meet applicable quality standards and regulatory requirements.

Your responsibilities will include:

• Maintaining, improving and further developing the Quality Management System in accordance with ISO 13485.
• Supporting ongoing compliance with the European Medical Device Regulation (EU MDR).
• Managing and updating technical and regulatory documentation.
• Preparing for and participating in internal and external audits, including follow-up on findings and corrective actions.
• Supporting quality-related activities involving external manufacturing and sterilisation partners.
• Contributing to quality control, product release processes and continuous improvement initiatives.
• Collaborating with internal stakeholders to ensure quality and regulatory requirements are embedded in day-to-day operations.
• Supporting new product developments, process improvements and future business growth from a QA/RA perspective.
• Taking increasing ownership of quality and regulatory projects as your experience and responsibilities evolve.

Who are we looking for?

We are looking for someone who brings the right balance of technical knowledge, maturity and interpersonal skills.

Ideally, you have:

• Approximately 4–8 years of experience in Quality Assurance and/or Regulatory Affairs within the medical device industry.
• Practical knowledge of ISO 13485 and EU MDR.
• Experience working with Quality Management Systems, audits and regulatory documentation.
• A hands-on, structured and solution-oriented approach.
• The confidence and maturity to work independently, make sound judgements and take ownership.
• Strong communication and interpersonal skills, allowing you to collaborate effectively across different functions and with external partners.
• A pragmatic mindset: you understand the importance of compliance while remaining attentive to operational realities.
• The ambition to develop professionally and gradually take on broader responsibilities.

You are comfortable in a growing organization where not everything is set in stone, priorities may evolve, and your contribution can make a tangible difference.

Fluency in English is essential. Knowledge of Dutch is an advantage, but not a requirement.

Real impact

Your work will directly influence product quality, regulatory compliance and the company's continued growth.

Room to grow

This is not a static specialist position. You will have the opportunity to take on broader responsibilities and potentially evolve towards a QA/RA management or PRRC role.

Work in a growing medical device company with short communication lines, direct involvement and room for initiative.

International exposure

Collaborate with international manufacturing and business partners in a company with a strong international commercial footprint.

Collaboration and ownership

Join a team where expertise is valued, collaboration is essential and you are trusted to make a difference.