Senior Regulatory & Quality Lead – Med Devices (IVD/MD)

Sener; Cerdanyola del Vallés; On-site; EUR 90,000 - 120,000; Full time

Benefits offered by this job

Flexible working hours

Remote work options

Remuneration plan (meal cards, private

Job summary

Sener Diagnostics is seeking a Senior Quality & Regulatory Compliance Manager to join our team in Cerdanyola del Vallès. The role centers on regulatory affairs for medical devices, acting as Technical Responsible and PRRC, and ensuring compliance with MDR/IVDR and ISO 13485 across the product lifecycle.

You will interact with AEMPS and customers, manage post‑market surveillance, and drive regulatory strategies for international expansion. A scientific degree and relevant experience are required.

Qualifications

• University degree in a scientific field or equivalent regulatory experience.
• Extensive knowledge of medical device regulations and post‑market requirements.
• Experience in regulatory submissions and technical documentation.

Responsibilities

• Lead regulatory affairs and ensure compliance across the product lifecycle.
• Serve as Technical Responsible and PRRC for medical devices.
• Act as regulatory contact with authorities (AEMPS) and customers.
• Oversee risk management, quality systems, and post‑market surveillance.
• Manage regulatory changes, design changes impact, and audits (ISO13485).

Skills

Regulatory affairs

Quality management

Risk assessment

Post‑market surveillance

FDA compliance

Regulatory liaison

Documentation review

Education

Science degree (pharmacy/biology/chemistry/medicine)

Tools

ISO 13485

MDR 2017/745 or IVDR 2017/746

AEMPS regulations

PRRC requirements

Job description

Sener Diagnostics is seeking a Senior Quality & Regulatory Compliance Manager to join our team in Cerdanyola del Vallès. The role centers on regulatory affairs for medical devices, acting as Technical Responsible and PRRC, and ensuring compliance with MDR/IVDR and ISO 13485 across the product lifecycle.

You will interact with AEMPS and customers, manage post‑market surveillance, and drive regulatory strategies for international expansion. A scientific degree and relevant experience are required.