Summary:
Remote | Reports to EU-based Senior Director of Global Regulatory Affairs
Veracyte is seeking an experienced Regulatory Affairs Manager to lead regulatory activities related to EU IVDR compliance, labeling, and post-market surveillance (PMS) for its global IVD product portfolio (assays, software, and instruments). The role supports product development, global submissions, and lifecycle management while helping to shape regulatory strategy and cross-functional processes.
Key Responsibilities:
- Lead IVDR submissions and manage labeling (IFUs, safety data sheets, labels)
- Provide regulatory guidance for new product development and changes
- Support post-market surveillance and vigilance activities (e.g., complaints, PSURs)
- Prepare and review technical documentation for global regulatory submissions
- Support audits, inspections, and regulatory authority interactions
- Help develop regulatory policies and contribute to continuous improvement
- Represent RA in cross-functional and lifecycle management initiatives
- Support training on global labeling and post-market requirements
Qualifications:
- Bachelor’s or Master’s in Life Sciences, Engineering, or related field
- 5+ years of IVD regulatory affairs experience, especially for the EU market
- Strong knowledge of EU IVDR, ISO 13485, MDSAP, and global regulatory frameworks
- Experience with labeling, vigilance, and PMS programs preferred
- Excellent communication, analytical, and project management skills
- Self-motivated and effective in a remote, global team environment
Job sourced from Veracyte.