Manager or Senior Manager, Quality and Regulatory Affairs (Consulting)

at  Veranex Inc

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world’s most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.

• Provide strategic and hands on regulatory support to clients related to compliance (Reg. EU 2017/745 (MDR), Reg. EU 2017/746 (IVDR), MDSAP, ISO 13485, US CFR Title 21, QSR)
• Assess complex scientific / technical documentation to identify gaps and to provide support for improvement
• Manage projects in a structured way in direct contact with Clients, Competent Authorities and Notified Bodies - during audits, conformity assessments and with product specific regulatory issues
• Coach clients on implementation and remediation activities for Quality Management Systems and technical documentation
• Assist clients in successfully managing nonconformities, complaints, recalls, FSN, FSCA
• Participate in Veranex training programs and represent Veranex in congresses and fairs
  Qualifications