Sener is currently looking for Senior Quality & Regulatory Compliance Manager to join our team at our Cerdanyola del Vallès work centre. In order to improve people's living conditions, we develop instruments for the automation of microbiology and molecular biology laboratory processes in the clinical and industrial fields, with which we streamline workflows. Among all of them, AUTOPLAK stands out, as it is one of our star products that contributes to improving laboratory efficiency and quality of service.
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What you will do
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- Ensure that the company complies with all regulatory obligations.
- Verify that technical documentation is complete and up to date.
- Ensure that manufacturing and quality processes comply with regulations.
- Oversee product release and ensure conformity before placing devices on the market.
- Act as the regulatory contact with AEMPS and legal authorities and customers.
- Ensure proper incident reporting and corrective actions.
- Ensure that the conformity of devices is checked before release.
- Ensure that the technical documentation and EU declarations of conformity are maintained.
- Create the post-market surveillance plan and ensure that post‑market surveillance obligations are fulfilled.
- Ensure that reporting obligations (serious incidents, field safety corrective actions) are met.
- For authorised representatives: verify that the manufacturer has met all obligations.
- Responsible for FDA regulatory compliance, and generate and maintain TF, DHF and DMR.
- Participate in the development of new products, providing regulatory inputs and assessing the products comply with regulatory obligations.
- Defend audits (ISO13485, EMPS, customers…)
- Review the impact of new design and engineering changes in the regulatory frame of the product.
- Analyze complaints and investigation reports.
- SCAR follow-ups.
- Define preventive and correcti
📌 Senior Quality (Sardañola del Vallés)
🏢 Sener
📍 Sardañola del Vallés
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