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At Werfen, within the Clinical Software Business Unit, we are committed to developing secure, efficient, and innovative clinical applications and laboratory instrumentation systems. Our solutions enhance patient care and facilitate the management of information in hospitals and laboratories worldwide.
Within a medical device environment, collaborate with the QARA Manager to ensure regulatory compliance and certification of software products.
Key Accountabilities
You will be a key part of a team responsible for:
* Maintaining the quality system documentation processes and procedures adopted by the company.
* Investigating and resolving quality issues, implementing corrective and preventive actions to mitigate recurrence.
* Preparing software technical documents for regulatory submissions.
* Supporting regulatory submissions for market authorization of medical device products.
* Conducting internal assessments and audits to identify improvement areas and ensure adherence to procedures.
* Facilitating the approval process for software releases.
* Disseminating knowledge about the Quality System and regulatory requirements.
* Reviewing promotional and advertising materials.
* Overseeing post-market surveillance activities related to medical device products.
* Providing guidance and mentorship to lower-level QARA team members.
Networking/Key relationships
Key relationships within the Werfen Group include:
* Factory Lead and Solution Leaders
* Customers
* Application Lifecycle Manager (ALM)
* Notified Bodies and Competent Authorities for product regulatory compliance
* Collaborating with other companies within Werfen may also be required.
Minimum Knowledge & Experience
* Engineering, Computer Science, or related technical degree, or equivalent work experience.
* At least 5 years of experience in Quality Assurance or Regulatory roles, preferably in Healthcare.
* Additional Skills/Knowledge:
o Experience with medical device international regulations and standards (ISO 13485, ISO 14971, etc.).
o Experience with Medical device software lifecycle processes (IEC 62304).
o Experience with regulatory submissions (MDR/IVDR, FDA).
o Internal auditor qualification or knowledge of auditing techniques.
Skills & Capabilities
The ideal candidate will demonstrate:
* Proficiency in technical and conversational English.
* Teamwork and ability to work independently.
* Effective written and verbal communication skills.
* Good interpersonal skills, judgment, and analytical thinking.
* Strong time management and organizational skills.
What we offer:
* A meaningful project impacting laboratory software medicine worldwide.
* 3 days a week remote work.
* Multicultural and friendly team environment.
* Opportunities for professional development and ongoing training.
* Social benefits including canteen, nursery checks, English training, and more, according to the chemical agreement.
Our Purpose: We contribute to advancing patient care globally through innovative diagnostics.
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