Regulatory Affairs Specialist

About Action

Action is the fastest growing non-food discount in Europe.
We started our business with a small store in Holland in 1993 and today our company has grown into an international retail organization with more than 2,500 stores in 12 countries and almost 80,000 people of 136 nationalities and these numbers are growing every day.
Working for Action means having a solid and financially reliable employer, with a concrete and motivating approach.

Regulatory Affairs Specialist

The Regulatory Affairs Specialist will work closely with the Regulatory Affairs Manager, technical managers and product technologists to resolve authority cases, communicate requirements to testing laboratories, communicate technical aspects of the authority challenges regarding product safety, sustainability and provide responses to the authorities regarding product compliance.

In addition this function provides coordinating support to the compliance team as it relates to authority activities and team activities.

The focus is on the coordination of work with the authority cases, authority audits and communication with the authorities regarding technical product safety and sustainability requirements, and product compliance with the EU mandatory requirements.

Areas of responsibility

Authorities
• Daily monitors incoming authority cases to assign them for handling according to product category.
• Review incoming authority cases for document requests, and initiates requests within Action for the requested documents.
• Provides translation of the country authority requests, documentation and reports into English language.
• Manages authority case entries in TopDesk to ensure clear communication about the case to product technologists, technical managers and regulatory affairs managers.
• Conducts follow-up to ensure response to authorities is conducted on time and deadlines are met.
• Communicates technical in nature reasoning on regulatory matters.
• Obtains and provides proof of compliance documentation to authorities (Declaration of Conformity and test reports)
• Conducts checks of technical documents for consistency and completeness in accordance with the authority requests (Declaration of Conformity and test reports).
• Communicates with country stores regarding sealed (by authorities) product samples.
• Arranges shipments of sealed samples to test laboratories and provides testing instructions to test laboratories. Follows-up on deadlines related to test reports and communicates results to technical stakeholders.
• Engages in preparations for authority audits
• Contacts service providers to obtain quotes for external services as it relates to compliance activities.
• Contributes towards the protection of Action brand reputation through improved product safety compliance.

Training and Projects

• Develop Topdesk training modules
• Conduct Topdesk training for new administrative staff within the compliance team.
• Provide support in Topdesk training in country stores
• Collaborates with Product Technologists and Technical managers on special projects to ensure product compliance for identified categories.
• Leads special projects in countries to maintain product compliance (involves collaboration with product technologists to update article lists for local store articles labelling in accordance with local regulation.)
• Provides in-country training for compliance-related activities.
• Provides overviews of information stemming from authority audits for follow-up
• Coordinates work with product technologists and technical managers related to customer complaints for response towards authorities.
Systems & Reporting
• Conducts TopDesk authority cases data analysis
• Documents authority case overviews
• Creates overview of deadlines
Administration
• Maintains contracts with local providers (test laboratories and local experts)
• Handles invoices related to local providers.
• Obtains and checks invoices for authority requests
• Documents authority cases
• Makes product compliance-related overviews
• Organizes meetings and travel for the compliance team
• Processes travel declarations

Requirements - Hard skills

• HBO Education level (Bachelor’s degree at least)
• Working in product safety compliance, or having technical or legal educational background is a plus.
• Fluent in English and country language is essential.
• High level language translation abilities between the country language and English (and vice-versa) using technical terminology.
• Computer literate, MS Office, excellent Excel skills

Requirements - Soft skills

• Is cost conscious in everything they do, deliver true value to the business
• Exhibits high integrity
• Has a high degree of accuracy and attention to detail.
• Has excellent communication skills using technical terminology.
• Has ability to take direction and can work independently.
• Has ability to work as a team player showing respect, support and discipline.
• Has ability and confidence in working with different disciplines / departments.
• Demonstrates a high level of pragmatism.
• Takes ownership for his/hers areas of responsibility and makes sure that deadlines are met.
• Ability to prioritize and agility to shift priorities on a daily basis with a solid sense of urgency .