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