Intuitive
Regulatory Affairs Specialist(m/w/x)
Vollzeitnur vor OrtBerufserfahren
Aubonne
Neuer Job?Nejo!
Dein persönlicher KI-Karriere-Agent
HAHaemonetics S.A.
Scientific Affairs Specialist(m/w/x)
Signy-Avenex
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Preparing Clinical Evaluation Reports and systematic literature reviews for regulatory compliance at a medical device and diagnostics company. 2-5 years MedTech/IVD/Pharma experience with scientific writing and regulatory documentation skills required. Work in a collaborative cross-functional team.
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
Berufserfahrung
- 2 - 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- FDA
- EMA
- MDR
- IVDR
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Haemonetics S.A. erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
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HAHaemonetics S.A.
Scientific Affairs Specialist(m/w/x)
Signy-Avenex
VollzeitVor OrtBerufserfahren
Nejo KI-Zusammenfassung
Preparing Clinical Evaluation Reports and systematic literature reviews for regulatory compliance at a medical device and diagnostics company. 2-5 years MedTech/IVD/Pharma experience with scientific writing and regulatory documentation skills required. Work in a collaborative cross-functional team.
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
Berufserfahrung
- 2 - 5 Jahre
Ausbildung
- Bachelor-AbschlussODER
- Master-Abschluss
Sprachen
- Englisch – verhandlungssicher
Tools & Technologien
- FDA
- EMA
- MDR
- IVDR
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens Haemonetics S.A. erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Gefällt dir diese Stelle?
BetaDein Career Agent findet täglich ähnliche Jobs für dich.
Über das Unternehmen
Haemonetics S.A.
Branche
Healthcare
Beschreibung
The company supports scientific direction through product development, regulatory compliance, and innovation.
Noch nicht perfekt?
- Intuitive
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VollzeitPraktikumnur vor OrtEysinsab CHF 60.000 / Jahr - Fresenius Kabi SwissBioSim GmbH
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Vollzeitnur vor OrtSeniorEysins - SUSONITY
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Vollzeitnur vor OrtSeniorAubonne - BD Biosciences
EMEA Senior Marketing Manager Life Science Research(m/w/x)
Vollzeitnur vor OrtSeniorEysinsab CHF 160.000 - 205.000 / Jahr