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HA
Haemonetics S.A.
2mo ago

Scientific Affairs Specialist(m/w/x)

Signy-Avenex
Full-timeOn-siteExperienced

Description

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.

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Requirements

  • 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

Education

Bachelor's degree
OR
Master's degree

Work Experience

2 - 5 years

Tasks

  • 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 & Technologies

FDAEMAMDRIVDR

Languages

EnglishBusiness Fluent

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