Senior Quality & Regulatory Compliance Manager - Medical and In Vitro Devices

Sener is currently looking for Senior Quality & Regulatory Compliance Manager to join our team at our Cerdanyola del Vallès work center.

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.

We are looking for a senior professional to be responsible for regulatory affairs in Sener Diagnostics. The employee will be the Technical Responsible "Técnico Responsible” for medical devices in front of AEMPS and the Person Responsible for Regulatory Compliance (TR and PRRC) for in-vitro devices.

What you will do:

• 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 corrective actions.

• Review documentation from a regulatory point of view.

• Perform risk analysis and mitigation actions follow-up.

• Evaluate the legal frame to commercialize in new countries and collect all the documentation needed.

• Provide the needed information to legal representatives in each country to manage the issues found.

• Evaluate the regulatory impact of the issues found in the field.

What we expect from you:

1. Requirements to be “Técnico Responsable” for Medical Devices (Spain – Real Decreto 1591/2009 and RD 192/2023).

Professional Requirements

• A university degree in a scientific field (e.g., pharmacy, medicine, biology, chemistry).

• Alternatively, equivalent professional experience in medical devices may be accepted by the Spanish Agency of Medicines and Medical Devices (AEMPS).

Knowledge Requirements

• Knowledge of medical device legislation, including EU Regulations (MDR 2017/745 or IVDR 2017/746) and Spanish transpositions.

• Understanding of quality management systems (ISO 13485).

• Familiarity with risk management (ISO 14971).

• Knowledge of post‑market surveillance, vigilance, and incident reporting.

• Understanding of technical documentation and conformity assessment procedures.

2. Requirements for a PRRC (Person Responsible for Regulatory Compliance) – EU Regulation 2017/746 (IVDR)

Educational Requirements

The PRRC must meet one of the following:

• A university degree in law, medicine, pharmacy or another relevant scientific discipline AND at least 1 year of professional experience in regulatory affairs or quality management systems related to IVDs. OR

• 4 years of professional experience in regulatory affairs or quality management systems related to IVDs (no degree required).

Competence Requirements

• Deep understanding of IVDR 2017/746 requirements.

• Knowledge of technical documentation for IVDs.

• Expertise in quality management systems (ISO 13485).

• Knowledge of performance evaluation, analytical and clinical performance.

• Understanding of post‑market surveillance, vigilance, and trend reporting.

• Familiarity with UDI, labelling, and traceability requirements.

3. Previous experience in FDA compliance

What we offer:

These are some of the benefits you will enjoy at Sener:

• You will have the opportunity to participate in innovative and high-level technological projects at an international level, collaborating with a multidisciplinary and highly qualified team.
  

• You will enjoy better management of your time thanks to our flexible working hours and remote work policies.
  

• You will be able to optimise your salary with our flexible remuneration plan (meal cards, private medical insurance, childcare vouchers, etc.) and you will have life and accident insurance.
  

• We will take care of you with our physical and emotional wellness programme, which includes sports, workshops, etc.
  

• We will encourage your professional development, with technical training, skills, languages, etc. so that you can continue to grow and achieve your goals.
  

• We promote equal opportunities, diversity and inclusion of all people and we are certified as a Family Responsible Entity (efr).
  

If you identify with our values and want to be part of a leading international family engineering company, we are waiting for you! We want to go as far as you want to go.