Regulatory Affairs Specialist

Global description of the role

The RA Specialist is the regulatory expert in the field and supports Sakura Finetek Europe in achieving and maintaining regulatory compliance of products and processes for EMEAI. As RA Specialist you are responsible for enabling the overall regulatory strategy of Sakura Finetek Europe products by providing expert knowledge and guidance to the organization.

The RA Specialist has a good understanding of the regulatory domain within our organization, and has a deep understanding of the products and services, but also of the broader industry in which Sakura operates and the agencies that regulate it. The RA Specialist is acting as a liaison between the organization and local and international agencies to submit required forms and paperwork.

The RA Specialist will act as the Person Responsible for Regulatory Compliance (PRRC) as laid down in the 2017/746 IVD Regulation, article 15.

Key Responsibilities

·         Enable regulatory compliance, certification, and product registrations within the Sales and Marketing territory of Sakura Finetek Europe

·         Ensure the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date

·         Ensure the post-market surveillance obligations are met

·         Providing support to product quality, certification, and regulatory questions from distributors, regional business units, suppliers, and colleagues at Sakura Finetek Europe.

·         Initiate and maintain registrations in the European database for IVDR (EUDAMED)

·         Regularly reporting on compliance status and measures to both internal and external parties

·         Support compliance to all relevant directives (ea. WEEE, REACH, and ROHS).

·         Reviewing marketing, legal, and technical documentation (including case files and clinical research reports) to assess compliance

·         Provide regulatory input in product development projects and provide other departments with advice.

·         Advise stakeholders regarding regulatory requirements about product labeling and Safety Data Sheets for dangerous goods, and is responsible for the relevant document control

·         Maintaining a deep understanding of new and existing regulations that may impact our organization’s products and processes.

·         Collaboration and alignment with Sakura Global RA departments. Close cooperation with counterparts at SFA, SFJ and SSCL

·         Maintain data and files for future reference, particularly in the event of an audit by a regulatory agency

·         Realization of the personal targets, formulated in the performance review goals.

·         Realization of the department goals, formulated in the department plan.

·         Higher Vocational Education, bachelor’s degree in product safety, biology, chemistry, and/or other sciences fields

·         A minimum of 3 years working experience in the medical device industries

·         Have an international technical background preferred in pathology and or laboratory equipment

·         Knowledge and experience with product registration of IVD products

·         Fluent in English, both verbal and written

·         Experience with ISO 13485. Experience with WEEE, REACH and ROHS directives are considered a plus.