Data Analyst – Medical Devices (Regulatory & Operations Focus)

Contract Type: Full-time/ Fixed Term Contract, 12 months

Start ASAP Urgent requirement

Location: Slovakia, Bulgaria, Romania

Remote or hybrid depending on location

Role Overview:

We are seeking a confident and proactive Data Analyst to support regulatory and operational data initiatives within the Medical Devices space. This role sits within a growing data function supporting Regulatory Affairs and broader MedTech operations, with strong visibility across multiple business units.

Given the pace and evolving structure of the team, this position requires individuals who are quick learners, comfortable working with ambiguity, and confident engaging with senior stakeholders. The initial focus will be on data extraction, reporting, dashboard development, and metric definition, with opportunities to shape longer-term data strategy as the function matures.

Key Responsibilities:

Data Analysis and Reporting:

• Extract, clean, and analyze data from multiple internal systems used across Medical Devices and Regulatory functions
• Design, build, and maintain dashboards and reports to support regulatory, quality, and operational decision-making
• Develop meaningful KPIs and metrics aligned with regulatory performance, compliance tracking, and operational efficiency
• Translate complex datasets into clear, actionable insights for technical and non-technical stakeholders

Regulatory and Medical Device Support:

• Support Regulatory Affairs data needs related to submissions, approvals, renewals, and post-market activities
• Assist in tracking regulatory milestones, timelines, and compliance metrics across medical device portfolios
• Ensure data accuracy and consistency in line with medical device regulatory standards and internal governance
• Collaborate with regulatory, quality, clinical, and product teams to understand data requirements and reporting needs

Data Governance and Quality:

• Apply data quality checks and validation processes to ensure integrity and reliability of outputs
• Support data standardization efforts across systems and functions
• Adhere to data privacy, security, and compliance requirements, particularly within EU regulatory frameworks

Tools and Systems:

• Build and enhance dashboards using tools such as Power BI or equivalent reporting platforms
• Work with structured and semi-structured data from enterprise systems, databases, and spreadsheets
• Document data sources, methodologies, and reporting logic to ensure transparency and reproducibility

Stakeholder Collaboration:

• Work closely with cross-functional teams including Regulatory Affairs, Quality, Clinical, PMO, and Operations
• Engage confidently with stakeholders to clarify requirements and present insights
• Support evolving data office structures by contributing to best practices and scalable reporting solutions

Required Skills and Experience:

• Proven experience as a Data Analyst within Pharma, Biotech, Medical Devices, or another regulated industry
• Strong experience in reporting, dashboard development, and data visualization
• Hands-on experience with Power BI or similar analytics tools
• Solid understanding of data structures, metrics development, and analytical methodologies
• Ability to work independently in a fast-paced, evolving environment
• Strong communication skills with the confidence to engage with senior stakeholders
• High attention to detail and strong problem-solving mindset

Preferred Experience:

• Exposure to Regulatory Affairs, Medical Devices, or Quality-related datasets
• Experience supporting regulatory, compliance, or submission-related reporting
• Familiarity with EU data privacy and data transfer requirements
• Experience working within matrixed, global organizations

Personal Attributes:

• Fast learner with the ability to ramp up quickly in a new environment
• Confident, proactive, and comfortable operating with limited initial definition
• Adaptable and resilient in a changing organizational structure
• Strong sense of ownership and accountability