Medical/Regulatory Writer
Amsterdam
Netherlands
€70,000/year
Permanent
Medical & Regulatory Affairs
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.
James Allen
Submit Your CV
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