JOB SUMMARY
Within a medical device environment, work with the QARA Manager to ensure regulatory compliance and certification of software products.
KEY ACCOUNTABILITIES
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:QARA Manger, QA Leads, Validation LedFactory Lead and Solution LeadersCustomerApplication Lifecycle manager (ALM)Notified Bodies and Competent Authorities for product regulatory compliance.This position may also require cooperating with other companies inside Werfen.
MINIMUM KNOWLEDGE & EXPERIENCE REQUIRED FOR THE POSITION
Education: Engineer, computer Science or other Technical carrier, or equivalent work experience.Experience:A minimum of 5 years experience in Quality Assurance or Regulatory related, preferably within the Healthcare sector.Additional Skills/Knowledge: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).Desirable:Knowledge and experience working in medical device regulatory submissions (MDR/IVDR,FDA..)Internal auditor qualification for management systems or knowledge of auditing techniques.
SKILLS & CAPABILITIES
The ideal candidate for this position will exhibit the following skills and competencies:Good level of Technical and Conversional English.Team player with ability to work independently.Excellent and effective written and verbal communication skills.Excellent interpersonal skills, good judgment and analytical skills.Effective time management and organizational skills.
TRAVEL REQUIREMENTS:Up to 5% of time