Role Description Dankzij jou blijft de APK-kwaliteit in jouw regio op hoog niveau. Een baan met veel afwisseling, vrijheid en in een hecht team! - Je zorgt met steekproefcontroles dat de keuringen in jouw regio volgens de wet- en regelgeving verlopen. - Je ontmoet uiteenlopende mensen en hebt veel vrijheid en verantwoordelijkheid. - Je bent verantwoordelijk voor een integer APK beleid in jouw regio. - Je weegt af of het oordeel van keurmeesters goed onderbouwd is. - Je bouwt relaties op gebaseerd op wederzijds begrip en respect. - Je werkt zelfstandig vanuit huis en ontvangt je werkgebied via je telefoon. - Je bent vertegenwoordiger van RDW en neemt keurmeesters op een objectieve manier mee in jouw beslissingen. Qualifications - Actuele kennis van wet- en regelgeving. - Vermogen om situaties juist in te schatten. Requirements - Centraal in de regio wonen. - Bereidheid om je continu te blijven ontwikkelen. Benefits - Salaris tussen € 3000,- en € 4316,- bruto per maand (op basis van fulltime). - 8% vakantiegeld en een eindejaarsuitkering van 8,33% over het in dat jaar genoten salaris. - Goede werk-privébalans: 36 uur is fulltime en 4 x 9 uur werken behoort tot de mogelijkheden. - Fijne werkomgeving waarin je je eigen route mag uitstippelen. - Pensioenregeling via het ABP: wij betalen 70% van de premie. - 6 weken verlof per jaar. - Ruime km vergoeding (0,38 ct waarvan een deel netto en een deel bruto) of de mogelijkheid van een leaseauto (onder voorwaarden). - Aanvullende vergoedingen voor ambulante dagen. - Telefoon en laptop.

• Oversee projects ensuring adherence to applicable laws, regulations, and internal policies while driving successful project outcomes. • Spearhead the creation and implementation of compliance programs, transforming compliance requirements into actionable project plans. • Monitor project progress and compliance metrics, set ambitious yet achievable deadlines, and ensure high standards. • Act as the key liaison between compliance teams, project stakeholders, and department heads, fostering clear communication. • Conduct risk assessments to identify compliance gaps and project risks, and implement corrective actions. • Complete projects that meet compliance standards and set new benchmarks for quality and efficiency, ensuring certifications like ISO27001 are achieved.

• Collaboratively develop and implement global regulatory strategies across clinical development and commercial programs, including preparation and management of submissions • Act as primary liaison with regulatory agencies managing communications, meetings, inspections and responses to inquiries • Oversee preparation and submission of regulatory documents • Together with outside regulatory subject matter experts (consultants), provide strategic regulatory guidance to cross-functional teams including Clinical, CMC, Medical Affairs, Commercial, and others to align regulatory support with business goals • Provide strategic input to leadership on regulatory risk and risk mitigations • Stay current with evolving global regulatory requirements and trends, and communicate regulatory requirements, guidelines, and policy changes to internal stakeholders • Collaborate with Quality Assurance to ensure alignment between regulatory requirements, quality systems, and inspection readiness • Represent regulatory interests in product development governance committees and decision-making processes

• Review and approve labeling artwork (e.g., cartons, blisters, inserts, and labels) for regulatory compliance, readability, and alignment with approved labeling content. • Collaborate with Regulatory Labeling, Regulatory Affairs, Packaging, Quality Assurance, and external vendors to ensure timely and accurate artwork development. • Verify that artwork reflects approved applicable information from prescribing information, including dosage, administration, safety warnings, and product identification. • Training and oversight of additional FSP resources for artwork management • Ensure compliance with country-specific regulatory requirements, including FDA, EMA, and other global health authorities. • Maintain documentation of artwork reviews, approvals, and version control in accordance with SOPs. • Support the development and maintenance of country regional text lists (cRTL). • Review of package component labeling (PCL) source text for compliance with Health Authority regulations for the respective countries. • Participate in cross-functional meetings to support product launches, labeling updates, and change control processes. • Support continuous improvement initiatives related to artwork review processes and labeling systems.