Beschreibung

As a Scientific Affairs Specialist, you will play a key role in shaping product development and regulatory compliance. Your day-to-day responsibilities will involve collaborating with teams, preparing essential reports, and translating complex scientific data for diverse audiences.

Anforderungen

• •Bachelor’s degree in Life Sciences, Medicine, Pharmacy, or related field
• •2–5 years’ experience in MedTech, IVD, or Pharma
• •Experience in scientific writing, literature reviews, and regulatory/clinical documentation
• •Demonstrated ability in scientific communication and stakeholder engagement
• •Knowledge of product development and regulatory environments
• •Experience working cross-functionally with R&D, Clinical, Medical, Quality, Regulatory, and Marketing teams
• •Strong analytical, project management, and organisational skills
• •Excellent written and verbal communication skills in English
• •Ability to interpret complex data and contribute to scientific excellence

Aufgaben

• •Assist in implementing and updating the scientific strategy for assigned products
• •Monitor and apply relevant regulatory requirements to scientific programs and documentation
• •Prepare and update Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs)
• •Conduct systematic literature reviews and post-market clinical follow-ups
• •Collaborate with cross-functional teams to maintain scientific standards
• •Coordinate with vendors to ensure timely delivery of outsourced projects
• •Contribute to the design and reporting of clinical studies and real-world evidence projects
• •Assist in developing publication plans and translating scientific data for various audiences
• •Support the dissemination of scientific insights through publications and presentations
• •Review marketing materials and monitor scientific developments for product lifecycle management
• •Provide scientific data and literature summaries for product launches and regulatory submissions

Tools & Technologien