Activate JobCopilot
This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Regulatory Master (Remote). In this role, you will have the opportunity to lead regulatory planning and operations for Diagnostics Regulatory Affairs. The position is crucial for driving departmental efficiency and ensuring operational excellence. You will collaborate closely with the leadership teams to support a dynamic global IVD regulatory portfolio and will be responsible for bridging strategic plans with operational execution, making a meaningful impact on our organization’s success.
Accountabilities
- Provide leadership and strategic oversight for DRA operations, setting standards for operational excellence.
- Manage critical cross-organizational initiatives including M&A and site or portfolio changes.
- Oversee core processes, workflows, and documentation practices to drive operational excellence.
- Lead continuous improvement efforts and standardization of processes and tools.
- Develop and report on regulatory metrics and KPIs for data-driven decision-making.
- Coordinate planning cycles and long-range strategies within DRA leadership.
- Collaborate with key cross-functional stakeholders to support planning and lifecycle strategies.
- Contribute to enterprise-level initiatives requiring DRA operational leadership.
Requirements
- Bachelor’s degree in a scientific discipline; advanced degree preferred.
- 12+ years of regulatory affairs experience in IVDs or medical devices.
- Strong understanding of global regulatory requirements and submission pathways.
- Experience in regulatory operations, process management, and strategic planning.
- Proven ability to lead through influence in a complex, matrixed organization.
- Excellent communication, organizational, analytical, and business acumen skills.
- Strong collaboration and influencing skills across various business groups.
- Experience presenting complex information to senior leadership with clarity.
Benefits
- Flexible remote work options.
- Full-time schedule with potential for bonus and stock options.
- Commitment to a diverse and inclusive workplace.
- Opportunity to impact global IVD regulatory portfolio.
- Support for candidates with disabilities during application and interview processes.
Why Apply Through Jobgether?
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
#LI-CL1
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Your email job alert is now active!
