Medical/Regulatory Writer

Title: Medical/Regulatory Writer

Reporting To: COO

Industry: Life Sciences - Medical Devices

Salary: Negotiable - depends on experience

Location: Amsterdam

About the Company

A leading company in the development of Self-Care Medical Devices is looking for a talented professional to join their growing team. As one of the fastest-growing players in the consumer healthcare market, this company has been challenging the norms by delivering innovative self-care products to renowned global brands across the industry. If you have experience in regulatory and clinical document management and are familiar with FDA/EMA standards, this could be the next exciting step in your career!

Key Responsibilities:

• Prepare, review, and maintain regulatory documents including Clinical Study Reports (CSRs), protocols, Investigator Brochures (IBs), and consent forms.
• Ensure compliance with regulatory guidelines (FDA, EMA, ICH) and company standards.
• Collaborate with cross-functional teams (Clinical, Regulatory, Quality) to ensure technical document accuracy and consistency.
• Manage product complaints and ensure effective communication with customers and regulatory bodies.
• Provide support for clinical studies, including drafting trial protocols and patient recruitment materials.
• Work closely with Clinical Operations to align study design, regulatory submissions, and site communications.

Skills & Experience:

• Bachelor's or Master's degree in a related field with a solid understanding of biological/medicinal processes in humans.
• 5+ years of experience in Pharmaceuticals or Medical Devices.
• Knowledge of FDA, EMA, ISO 13485, and EU-MDR regulations.
• Understanding of Good Documentation, Manufacturing, and Clinical Practices (GDP, GMP, GCP).
• Familiarity with clinical trial processes and regulatory submission requirements.

The Offer:

• A rapidly growing corporate environment with exciting new opportunities.
• The satisfaction of seeing your work in pharmacies and drugstores worldwide.
• Close collaboration with top global brands and senior industry leaders.
• A flat organizational structure with a close-knit, dynamic team.
• Competitive salary with opportunities for international travel.
• A chance to influence product development and make a tangible impact.

If you're ready to take the next step in your career with a company transforming the future of self-care, we'd love to hear from you!

Apply now to be part of this exciting journey!

Darwin Recruitment is acting as an Employment Agency in relation to this vacancy.