Senior Healthcare Regulatory Specialist (saMD)

EU MDR Compliance:

• Achieve mandatory Medical Device Regulation certification to maintain European market access.
• Support Global Certification Processes: Lead MDR certification and other accreditation (ISO, C5) processes across target jurisdictions to enable market expansion and continuance.
• Establish Compliant Governance Framework : Build robust governance systems that stakeholders and customers can trust, ensuring business integrity and regulatory adherenc.

Risk Mitigation & Business Protection:

• Prevent regulatory fines and reputational harm that could impact our ability to serve patients and healthcare providers.
• Process Optimization: Continuously assess and improve compliance processes to align with the dynamic needs of the increasingly regulated digital healthcare industry.

What We Believe In:

• Focus on results – we're here to make an impact.
• Think like an owner – take responsibility, drive outcomes.
• Keep it simple, keep it lean – smart solutions over complexity.