(T-587) | Quality Assurance Regulatory Affairs Manager

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Immunoassay business line, we research, develop, and manufacture customized assays and biomaterials.

We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

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

Key Accountabilities

Be a key part of a team where you will :

• 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.
• Conduct internal assessments and audits to identify areas for improvement and ensure adherence to established procedures.
• Facilitate the approval process for software releases.
• Disseminating knowledge about the Quality System and regulatory requirements.
• Review Promotional and advertising materials.
• Oversee post-market surveillance activities related to medical device products.
• Offer guidance and mentorship to QARA team members at lower levels

Networking / Key relationships

The main relationships within to the Werfen Group are :

Minimum Knowledge & Experience required for the position :

Skills & Capabilities :

The ideal candidate for this position will exhibit the following skills and competencies :

What we offer :

Our Purpose : We contribute to the advancement of patient care around the world through innovative specialized diagnostics

JOIN US!