RAQC specialist in Europe
A Japanese Global manufacturing company is looking for an experienced Regulatory Affairs and Quality Assurance Specialist who can act as the Person Responsible for Regulatory Compliance defined in the European IVDR. When joining the company as its new regulatory member in Europe, you will function independently as the key contact for regulatory issues within Europe but will also be working closely with the Japan Headquarters and its other overseas members to share knowledge and expertise in support of team activities.
Duties and Responsibilities
Ensure the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured before a device is released.
Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up to date.
Ensure the post-market surveillance and vigilance reporting obligations are complied with in accordance with IVDR and cooperate with those involved.
Provide guidance and interpretation of IVDR requirements for the design and development of new products. Recommend and implement compliance strategies for existing, new, and proposed products or product changes.
Act as the main point of contact between their companies for new product development and changes to existing products.
Work closely with the Regulatory Affairs and Quality Management teams in Japan to establish robust regulatory/quality systems that comply with IVDR.
Work closely with the Design and Development teams in Japan to ensure the implementation of requirements from IVDR.
Assist and coordinate product performance evaluations or clinical trials in Europe.
Manage the establishment, documentation, implementation, and maintenance of QMS procedures.
Lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Knowledge and Skills
University degree in scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems related to medical devices
Four years of professional experience in European regulatory affairs or quality systems management related to medical devices
English business level or above.
Experience in European In Vitro Diagnostic Directive (IVDD) for Class A, B and C products such as laboratory and Point of Care IVD products
Experience with ISO, GMP/QSR, and other regulatory issues related to IVD medical products
Experience in regulatory affairs or quality systems for IVD medical products
Candidate must be eligible to work without any restrictions as no visa support given