Scientific Documentation And Medical Device Design Specialist. Ne

Scientific Documentation And Medical Device Design Specialist.
Ne
Liguria, Ne

Scientific Documentation and Medical Device Design Specialist Alchimia is one of the leading European manufacturers of medical devices for ophthalmic surgery and tissue banks. With our expertise in the fields of chemistry, microbiology, and pharmacology, at Alchimia we have adopted this rule: we design each medical device as if it were intended for ourselves. Since our foundation in 1993, all our products have been developed in collaboration with opinion leaders and the scientific community before being released to the market. This allows us to offer safe, useful, and effective solutions to improve the daily operations of medical staff and the quality of life of their patients. Our commitment to research makes us a reliable partner, able to provide ongoing training and updated scientific information to our distributors and product users. Thanks to the Alchimia team, we now have a network of over 60 independent distributors across Europe and the world, capable of providing fast local service to all our customers. To expand our Research and Development team, we are looking for a Scientific Documentation and Medical Device Design Specialist. Main Responsibilities Draft and update technical documentation for medical device design in compliance with national and international regulations (MDR, ISO 13485, FDA, etc. ). Support the R&D team in collecting and organizing the technical information needed for device development, drafting protocols, and preparing final reports for design validation, biological evaluation, and risk management. Conduct literature reviews and analyze scientific data. Manage the documentation lifecycle, ensuring completeness, accuracy, and traceability. Collaborate with internal teams (Quality Assurance, Quality Control, Regulatory Affairs, and Production) to ensure documentation alignment with regulatory requirements. Participate in internal and external audits, providing the required documentary support. Assist in drafting scientific publications related to developed or in-progress medical devices. Requirements Bachelor's degree in Biomedical Engineering, Materials Science, Biology, Pharmaceutical Sciences, or related fields. Preferably, at least 2 years of prior experience in the technical documentation of medical devices. Knowledge of MDR, ISO 13485, FDA regulations, and validation and verification procedures. Excellent technical writing skills, document management, data analysis, and experience with scientific publications. Familiarity with document management software (e. g. , PLM, ERP) is a plus. Proficiency in written and spoken English. Analytical and detail-oriented mindset. Strong teamwork and communication skills. What We Offer Continuous training and professional development opportunities. A competitive compensation package commensurate with experience and qualifications. This job posting is open to candidates of all genders, in compliance with applicable laws (L. 903/77 and L. 125/91). Seniority level Associate Employment type Full-time Job function Research Industries Medical Equipment Manufacturing and Pharmaceutical Manufacturing J-18808-Ljbffr