Regulatory Affairs Specialist

January 22

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Velsera

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Velsera is a company dedicated to powering precision medicine and enhancing the healthcare and life sciences ecosystem through data and actionable insights. It offers advanced genomics interpretation platforms aimed at improving patient care by evaluating clinical significance and generating clinically actionable reports. By integrating workflows, Velsera supports NGS test menus and accelerates 'omics results delivery through automated services. Its technology employs AI and machine learning to automate analysis, providing qualitative results for clinical reporting. Velsera collaborates with research teams, offering tools and expertise in data integration for insights across healthcare and research sectors. With its extensive platform and partnerships, Velsera is a leading provider in the omics analytics market, supporting top pharmaceutical companies and clinical labs globally.

501 - 1000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

🤖 Artificial Intelligence

📋 Description

• Identify relevant regulations for diagnostic software tools in the EU and other markets. • Perform detailed gap analyses to assess compliance with IVDR requirements and other global regulations for software as a medical device (SaMD). • Develop and implement plans to address and correct compliance gaps. • Prepare and maintain documented evidence to support regulatory compliance efforts. • Contribute to the development of the company's regulatory strategy. • Assist in preparing regulatory submissions and technical documentation for Velsera and its customers, ensuring accuracy and compliance. • Lead the implementation of IVDR compliance strategies for Velsera’s software tools, acting as the primary regulatory contact in the EU. • Support the broader organizational goal of expanding compliance capabilities for future regulatory frameworks across global markets. • Participate in post-market surveillance activities to monitor product performance and compliance. • Monitor changes to regulatory requirements and changes in a timely manner. • Communicate regulatory requirements and procedures effectively across the organization. • Provide training and support to teams on regulatory practices and tools. • Assist the company in preparing for external audits from customers and regulatory bodies. • Work closely with cross-functional teams to integrate regulatory compliance into all areas of the business. • Mentor team members, fostering a culture of compliance and continuous improvement.

🎯 Requirements

• Bachelor's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field. • 5+ years of relevant industry experience, with a primary focus on in-vitro diagnostics and/or medical device software. • Experience with IVDR regulations is required; familiarity with other international regulatory frameworks is a plus. • Proven experience in performing gap analyses and implementing corrective actions. • Knowledge of standards applicable to Software as a Medical Device (SaMD), particularly those incorporating AI. • Experience in preparing regulatory submissions and supporting regulatory strategy development. • Knowledge & experience of managing compliance using software tools • Familiarity with quality management systems and standards (ISO 13485, IEC 62304). • Certifications in regulatory affairs (e.g., RAC) are a plus. • Positive attitude and a solution-oriented approach. • Excellent written, verbal, and presentation skills. • Ability to think proactively and drive improvements in regulatory compliance. • Strong organizational and project management skills. • Collaborative mindset with the ability to work effectively in cross-functional teams. • Ability to coach and motivate others to inspire a positive relationship with the regulatory department.