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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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