Global Regulatory Affairs Specialist IVD Devices

Wolfram; Salamanca; Sur place; EUR 27 000 - 29 000; Plein temps

Résumé du poste

Waters is hiring a Regulatory Affairs Specialist to lead regulatory activities for in vitro diagnostic devices across the product lifecycle in Salamanca, Spain. You will collaborate with R&D, QA, Manufacturing, Clinical, Medical, and Marketing to ensure global market access.

The role requires a scientific background, strong regulatory interpretation abilities, and excellent English communication. A dynamic, regulated environment awaits.

Qualifications

• Bachelor's degree in Biology, Biotechnology, Biomedical Sciences, Pharmacy, Life Sciences, or related field.
• 1-3 years of professional Regulatory Affairs or related experience.
• Strong written and verbal communication skills in English.

Responsabilités

• Develop and maintain global regulatory strategies for IVD devices.
• Prepare and maintain regulatory submissions and product registrations.
• Support compliance with FDA, EU IVDR EU 2017/746, UK, Health Canada, and other regulations.
• Review labeling, IFUs, and promotional materials for regulatory compliance.
• Support interactions with regulatory authorities and Notified Bodies.
• Assist lifecycle management, change control, and post-market activities.

Connaissances

English proficiency

Regulatory knowledge

Cross-functional collaboration

Formation

Bachelor's degree in Biology/related

Master's in Regulatory Affairs (plus)

Description du poste

Waters is hiring a Regulatory Affairs Specialist to lead regulatory activities for in vitro diagnostic devices across the product lifecycle in Salamanca, Spain. You will collaborate with R&D, QA, Manufacturing, Clinical, Medical, and Marketing to ensure global market access.

The role requires a scientific background, strong regulatory interpretation abilities, and excellent English communication. A dynamic, regulated environment awaits.