Regulatory Affairs Strategist – Medical Devices (Interim)

Vi-Jo - Enlightened Consulting; Antwerpen; Sur place; EUR 68 880 - 110 208; Plein temps

Avantages offerts par ce poste

Flexible freelance conditions

Opportunity to work in a multicultural environment

Résumé du poste

A leading consulting firm in Antwerp, Belgium seeks an experienced Regulatory Affairs Consultant for an interim assignment with a prominent medical device company. The role involves developing regulatory strategies, coordinating submissions, and ensuring compliance with EU MDR. Ideal candidates have a strong track record in Regulatory Affairs, are organized, and can work independently. The position offers flexibility within a professional consulting framework and the chance to contribute to a high-impact project in the healthcare sector.

Qualifications

• Solid track record in Regulatory Affairs within the medical device industry.
• Hands-on and well-organized with the ability to work independently.
• Fluent in English; additional European languages are a plus.

Responsabilités

• Develop regulatory strategy and create detailed regulatory plans.
• Review development quality reports for regulatory submissions.
• Plan and coordinate regulatory submissions for product certification.

Connaissances

Regulatory Affairs expertise

Knowledge of EU MDR

Fluency in English

Description du poste

Excellence Squad is a European consulting firm specializing in Operational Excellence, Quality & Compliance, and Project Leadership across industries.

We help organizations achieve measurable results through structured execution and performance excellence.

Our client, a leading medical device company based in Belgium, is looking for an experienced Regulatory Affairs Consultant to join their team on an interim basis until the end of the year.

Your Role

As Regulatory Affairs Consultant, you will:

• Develop regulatory strategy and create detailed regulatory plans
• Review development quality reports and plans to ensure information required for regulatory submissions and product compliance is adequate
• Plan, generate, and coordinate regulatory submissions for product certification and approvals
• Coordinate conformity assessment strategies and plans required to support regulatory submissions
• Review and approve product labeling and product-related marketing communications
• Maintain existing regulatory filings and licenses, managing updates and related change control
  
  
  

Your Profile

You have a solid track record in Regulatory Affairs within the medical device industry, with strong knowledge of EU MDR and conformity assessment processes. You are hands-on, well-organized, and able to work independently in a dynamic environment. Fluency in English is required; additional European languages are a plus.

Why Join

• Contribute to a strategically important project within a leading medical device company in Europe
• Work in a multicultural, performance-oriented, and compliance-driven environment
• Apply your Regulatory Affairs expertise in a complex, high-impact setting
• Flexible freelance conditions within a professional consulting framework
  
  
  

What's On Offer

A full-time interim assignment (flexibility possible) with a well-established international medical device company in Belgium.

Interested in joining us?

Please submit your freelancer application, including your CV and a brief note outlining your relevant Regulatory Affairs and medical device experience.

Join Excellence Squad and help drive quality, compliance, and regulatory excellence.

At Excellence Squad, we welcome applications from all qualified individuals regardless of race, ethnicity, gender, sexual orientation, religion, or disability status. We do not accept inquiries from recruitment, staffing, or advertising companies.