Role Summary
ARKRAY is looking for an experienced Regulatory Affairs Specialist who can act as the Authorized Representative regarding the Person Responsible for Regulatory Compliance defined in the European IVDR. When joining ARKRAY as its 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 Quality Team in Ireland, Japan Headquarters, and its other overseas members to share knowledge and expertise in support of team activities.
Duties and Responsibilities
PRRC
* 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.
Regulatory Affairs
* 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 ARKRAY companies and Notified Bodies/Competent Authorities for new product development and changes to existing products.
* a) Work closely with the Regulatory Affairs and Quality Management teams in Japan to establish robust regulatory/quality systems that comply with IVDR.
* b) Work closely with the Design and Development teams in Japan to ensure the implementation of requirements from IVDR.
* c) Assist and coordinate product performance evaluations or clinical trials in Europe.
* d) Review and approve technical documents to assemble an IVDR-compliant technical file and keep them up to date.
Knowledge and Skills
Required/Preferred
* Four years of professional experience in European regulatory affairs or quality systems management related to medical devices.
* English business level or above.
* Experience in IVDR 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.
* MDR regulatory and/or Quality System Management experience preferred.
Working Location
ARKRAY IRELAND LIMITED.
First Floor, 43 - 49, Sir John Rogerson's Quay, Dublin 2, Dublin, D02 Kv60, Ireland
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