CQ/RA Specialist BeNeLux

Johnson & Johnson Co.; Belgique; On-site; EUR 63,000 - 98,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Bereavement leave

Well-being programs

Insurance plans

Job summary

Johnson & Johnson in Diegem, Belgium is recruiting a CQ/RA Specialist to support the Benelux Commercial Quality team. You will help maintain the Quality Management System for MedTech activities in Belgium and Luxembourg, collaborating with local partners and regional teams to ensure regulatory compliance.

The role requires Quality/Regulatory Affairs experience, strong communication, and the ability to train others.

Qualifications

• Previous Quality and/or Regulatory Affairs experience.
• Ability to collaborate across local and EMEA-based teams.
• Strong communication and influencing skills.
• Results-oriented with focus on quality and operational excellence.
• Knowledge of Good Documentation Practices and Data Integrity.
• Proficiency with Microsoft Office applications.
• Fluent English and Dutch or French.

Responsibilities

• Support QMS and quality activities across Belgium and Luxembourg.
• Manage CAPAs, non-conformances, investigations, Field Safety Notices, recalls, document control, and training systems.
• Support implementation of corporate quality standards, procedures, and compliance activities.
• Plan and lead internal audits and supplier audits.
• Coach and train employees on quality topics.
• Lead change control activities and support quality system improvements.
• Maintain quality records and metrics.
• Collaborate with local and global Johnson & Johnson departments.

Skills

Quality RA exp

Cross-functional collab

Strong communication

Analytical mindset

Training delivery

Microsoft Office

AI concepts awareness

Dutch or French

Education

Bachelor's degree or equivalent

Tools

ISO 13485 knowledge

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function: Regulatory Affairs Group

Job Sub Function: Regulatory Product Submissions and Registration

Job Category: Professional

All Job Posting Locations: Diegem, Flemish Brabant, Belgium

Job Description

DePuy Synthes is recruiting for a CQ/RA Specialist located in Diegem, Belgium.

Purpose

We are looking for a CQ/RA Specialist to join the Benelux Commercial Quality team at DePuy Synthes.

In this role, you will support and maintain the Quality Management System (QMS) for the MedTech businesses in Belgium and Luxembourg. Working closely with the Commercial Quality Manager, Commercial Quality colleagues across the Benelux region, and local commercial teams, you will help ensure compliance with applicable quality requirements, company standards, and regulatory expectations.

Are you interested in helping strengthen quality and compliance while working across commercial, quality, and healthcare environments?

You will be responsible for

In this role, you will contribute to the effective operation of the Quality Management System and support quality activities across Belgium and Luxembourg. You will work closely with local and regional partners to help ensure quality processes are executed consistently and in accordance with company and regulatory requirements.

Key responsibilities include

• Supporting the Quality Management System (QMS) and associated quality activities across Belgium and Luxembourg
• Managing and supporting quality processes including CAPAs, non-conformances, complaint investigations, Field Safety Notices, recalls, document control, and training systems
• Supporting implementation and maintenance of corporate quality standards, procedures, and compliance activities
• Planning and leading internal audits and supporting supplier audits, where applicable
• Coaching and training employees on quality-related topics and requirements
• Leading change control activities and supporting quality system improvements
• Collecting, reviewing, and maintaining quality documentation and supporting data
• Creating and maintaining standard operating procedures related to interactions with contractors
• Supporting quality projects, implementation of new digital tools, and continuous improvement initiatives
• Participating in committees and project teams focused on quality and regulatory compliance topics
• Monitoring and maintaining quality records, project outcomes, and quality metrics in an accurate and timely manner
• Collaborating with local and global Johnson & Johnson departments to support quality and compliance objectives

Qualifications / Requirements

We are looking for someone who combines quality and compliance knowledge with strong collaboration, communication, and organizational skills.

Education

• Bachelor's degree or equivalent business experience
• Knowledge of Quality Management Systems and/or the healthcare industry is preferred

Experience & Skills

Required

• Previous Quality and/or Regulatory Affairs experience
• Ability to build effective relationships and collaborate across local and EMEA-based business and quality teams
• Strong communication, interpersonal, and influencing skills
• Results-oriented approach with a focus on quality and operational excellence
• Ability to build trust and credibility with customers, employees, and internal partners
• Strong self-awareness and adaptability
• Analytical mindset and process-oriented approach
• Experience delivering training to employees and teams
• Strong awareness of Good Documentation Practices and Data Integrity principles
• Proficiency with Microsoft Office applications, including Excel, Word, and PowerPoint
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

Preferred

• Knowledge of Quality Management Systems, including ISO 13485
• Experience working within the healthcare industry
• Experience working within a mid-sized or multinational organization
• Internal ISO auditor certification

Language Requirements

• Fluent English and Dutch or French, both written and spoken

What we offer

We offer a collaborative environment where learning, innovation, and professional development are encouraged.

In this role, you will have the opportunity to work across quality, regulatory, and commercial functions while supporting products and solutions that help improve patient outcomes.

Our commitment to inclusion

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.

We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.

Required Skills:

Preferred Skills: Analytical Reasoning, Brand Research, Business Behavior, Design Thinking, Detail-Oriented, Industry Analysis, Market Research, Package and Labeling Regulations, Problem Solving, Process Oriented, Product Packaging Design, Project Management, Project Support, Proof Reading Software, Quality Assurance (QA), Regulatory Affairs Management, Regulatory Compliance, Risk Assessments, Safety-Oriented

The anticipated base pay range for this position is: €63300,00 - €97635,00

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.