We are seeking a Senior R&D Scientist for our client, a leading international company currently expanding in the aesthetic medicine and dermatology sector. You will be responsible for leading critical projects from concept through design transfer, closing technical gaps and shortening timelines. You will collaborate closely with cross-functional teams to ensure every device we launch meets the highest standards of ISO 13485, EU MDR 2017/745, and global market requirements.
Responsibilities
• Design and optimize injectable formulations (e. g., HA gels, microsphere suspensions, depot systems) with a focus on rheology, sterility assurance, and syringe/needle compatibility.
• Define critical process parameters (CPP), draft process validation protocols, and collaborate with Manufacturing to scale products from lab to GMP cleanroom production.
• Generate technical dossiers, risk management documentation (ISO 14971), and design history files in compliance with MDR and FDA 21 CFR 820.
• Identify new excipients, release technologies, and device components that enhance safety and clinical value.
• Mentor junior scientists and act as a scientific liaison for Clinical, Regulatory, and Marketing teams.
• Monitor scientific advancements and competitive activity in injectable aesthetics, drug-device combinations, and regenerative medicine.
Professional Experience
• 8 to 10 years of hands-on R&D experience with injectable medical devices or parenteral drug-device combinations.
• Proven expertise in aseptic techniques, rheological characterization, and cleanroom scale-up.
• Deep knowledge of ISO 13485, ISO 14971, EU MDR, and relevant FDA guidelines for Class III devices.
• Strong analytical skills with proficiency in Design of Experiments (DoE) and statistical analysis.
Requirements
• Fluency in English.
• MSc/PhD in Biomedical Engineering, Chemistry, Pharmacy, Biomaterials Science, or related field.
Additional Requirements & Interpersonal Skills
• Excellent communication and problem resolution skills.
• Ability to thrive in dynamic, fast-paced environments.
• Constant curiosity and agility to learn.
What We Offer
• Opportunity to contribute to the growth of an international company in full expansion.
• Social benefits and continuous training.
Please note: All applications will be reviewed starting in early September due to the August summer holiday period.
#J-18808-Ljbffr