Clinical Writer

THE COMPANY

A leading innovator in spinal and orthopedic medical device solutions dedicated to developing cutting-edge technologies that transform patient care and clinical practice. The company combines scientific excellence regulatory expertise and clinical evidence to deliver innovative solutions across multiple regulated markets (EU US and beyond).

Operating at the intersection of medical innovation and regulatory compliance we are committed to the highest standards of clinical and scientific integrity.

THE OPPORTUNITY

We are seeking an experienced Clinical Writer to participate in product development and lead the creation of high-quality clinical documentation.

You will play a key role in developing clinical strategies and ensuring scientific excellence across our product portfolio.

RESPONSIBILITIES

Your key responsibilities will include:

• Participate in the development of new products and author clinical development plans
• Lead clinical literature reviews and compile state-of-the-art evidence therapeutic alternatives and reference treatments
• Participate in developing clinical evaluation strategies
• Independently author clinical evaluation plans and reports with critical analysis of clinical data
• Independently author PMCF (Post-Market Clinical Follow-up) plans and evaluation reports
• Participate in product risk management
• Collaborate with the regulatory team to draft responses to clinical questions from Notified Bodies and Regulatory Authorities
• Ensure consistency scientific quality and regulatory compliance of all documentation
• Ensure comprehensive and rigorous evaluation of clinical data
• Collaborate with regulatory affairs to prepare responses to clinical questions
• Support responses to Notified Bodies and Regulatory Authority inquiries
• Maintain consistency and scientific quality across all clinical documentation
• Guarantee regulatory compliance according to internal procedures and regulatory requirements
• Support product risk management from a clinical perspective

REQUIREMENTS

• Solid knowledge of statistical methods applied to clinical data analysis
• Clear and concise writing style with training in clinical literature research methodology
• Deep knowledge of medical device regulations and standards: ISO 14971 GCP ISO 14155 MEDDEV 2.7/1 rev4 EU Regulation 2017/745 and associated MDCG guidance
• Advanced English proficiency (C1 level) for technical and professional writing
• Bachelors degree or higher in a scientific field; specialization in clinical research is valued
• Minimum 5 years of significant experience in a similar clinical role

WHY JOIN

• Shape Clinical Documentation: Directly influence the clinical evidence and documentation strategy for innovative medical device products
• Scientific Excellence: Contribute your writing expertise to ensure the highest scientific quality in clinical documentation
• Professional Autonomy: Work independently on clinical plans reports and evaluations with significant responsibility
• Meaningful Impact: Play a key role in getting innovative solutions to patients through rigorous clinical documentation
• Work-Life Balance: Flexible telework policies and commitment to disconnection
• Benefits Package: Restaurant vouchers and eco-friendly transport allowance