Scientific Affairs Specialist

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further — Haemonetics is your employer of choice.

Job Details

Role Overview

The Scientific Affairs Specialist at Haemonetics supports the company’s scientific direction by assisting in product development, regulatory compliance, and innovation. This role requires a solid understanding of scientific principles, clinical research, and regulatory requirements to contribute to product evaluations, documentation, and scientific communication, helping uphold Haemonetics’ reputation for scientific excellence.

Main Responsibilities

• Assist in implementing and updating the scientific strategy for assigned Haemonetics products, ensuring alignment with corporate objectives and market needs.
• Support the monitoring, interpretation, and application of relevant regulatory requirements (FDA, EMA, MDR, IVDR, local authorities, ISO) to scientific programmes and documentation.
• Prepare and update Clinical Evaluation Reports (CERs), Performance Evaluation Reports (PERs), and clinical benefit-risk assessments (CRBAs) for assigned products, under supervision.
• Conduct systematic literature reviews (LSRs), post-market clinical follow-ups (PMCF), and adverse event analysis to support ongoing product evaluations.
• Collaborate with cross-functional teams (clinical affairs, medical affairs, R&D, marketing, quality, regulatory) to facilitate communication and ensure scientific standards are maintained.
• Coordinate with vendors (e.g., medical writing agencies, CROs, literature review providers) to support timely delivery and quality of outsourced projects.
• Contribute to the design, execution, and reporting of clinical studies, registries, surveys, and real-world evidence projects as needed for clinical evaluation.
• Assist in developing publication plans and translating complex scientific data into audience-appropriate content for internal and external stakeholders.
• Support the development and dissemination of scientific insights through peer-reviewed publications, conference presentations, and other forums for scientific exchange.
• Review marketing materials and contribute to product lifecycle management by monitoring scientific developments, post-market studies, and user feedback.
• Provide scientific data, literature summaries, and responses to authority queries to support product launches and regulatory submissions.

Qualifications and Prerequisites

• Bachelor’s degree in Life Sciences, Medicine, Pharmacy, or related field required; advanced degree preferred.
• 2–5 years’ experience in MedTech, IVD, or Pharma, including experience in scientific/medical writing.
• Experience in scientific writing, literature reviews, and regulatory/clinical documentation (e.g., CERs, PERs, PMCF).
• Demonstrated ability in scientific communication (publications, abstracts, posters) and stakeholder engagement.
• Knowledge of product development, regulatory environments (FDA, EMA, MDR, IVDR), and post-market surveillance.
• Experience working cross-functionally with R&D, Clinical, Medical, Quality, Regulatory, and Marketing teams is an asset.
• Strong analytical, project management, and organisational skills with the ability to manage multiple priorities.
• Excellent written and verbal communication skills in English; proficiency in additional European languages is an asset.
• Ability to interpret complex data and contribute to scientific excellence.

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