Senior QARA Specialist

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 Led
• Factory Lead and Solution Leaders
• Customer
• Application 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