Manufacturing Specialist (Senior Manufacturing Tech)

Werfen; Madrid; Híbrido; EUR 40.000 - 60.000; Jornada completa

Descripción de la vacante

A family-owned healthcare company in Madrid is looking for a Regulatory Compliance Specialist. You will work with the QARA Manager to ensure compliance for software products, maintain quality documentation, and support regulatory submissions. The ideal candidate has over 5 years of experience in Quality Assurance, particularly within the medical device sector. This role offers exciting opportunities for professional development and a flexible working arrangement.

Servicios

Flexible work arrangement

Professional development opportunities

Ongoing training

Social benefits: Canteen, nursery check, English training

Formación

• 5+ years experience in Quality Assurance or Regulatory roles in Healthcare.
• Familiar with ISO 13485, ISO 14971, IEC 62304 regulations.
• Experience with medical device regulatory submissions.

Responsabilidades

• Ensure compliance and certification for software products.
• Maintain quality system documentation and processes.
• Investigate quality issues and implement corrective actions.
• Support preparation for regulatory submissions.

Conocimientos

Quality Assurance

Regulatory compliance

Technical English

Medical device standards

Descripción del empleo

About the Company

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. Through our Immunoassay business line, we research, develop, and manufacture customized assays and biomaterials.

Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Role Overview

Within a medical device environment, work with the QARA Manager to ensure regulatory compliance and certification of software products.

Collaborate in maintaining the quality system documentation processes and procedures adopted by the company.

Investigate and resolve quality issues, implementing corrective and preventive actions to mitigate recurrence.

Coordinate and support the preparation of software technical documents appropriate for regulatory submissions.

Support the regulatory submissions for market authorization for medical device products.

Facilitate the approval process for software releases.

Disseminating knowledge about the Quality System and regulatory requirements.

Oversee post-market surveillance activities related to medical device products.

A meaningful project that will impact the quality of laboratory software medicine worldwide.

Networking / Key Relationships

Factory Lead and Solution Leaders

Qualifications

• A minimum of 5 years experience in Quality Assurance or Regulatory related, preferably within the Healthcare sector
• Knowledge and experience working with medical device international regulations and related standards (ISO 13485, ISO 14971,..).
• Knowledge and experience working in Medical device software life cycle process (IEC 62304)
• Knowledge and experience working in medical device regulatory submissions (MDR / IVDR,FDA..)
• Good level of Technical and Conversional English.

Benefits

• ~3 days a week working from home
• ~ Exciting opportunities for professional development.
• ~ Ongoing training
• ~ Social benefits : Canteen, nursery check, English training...