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Sirona Medical · 21 hours ago

Regulatory Affairs Manager

United States

Full-time

Remote

Senior Level

$130K/yr - $160K/yr

7+ years exp

Sirona Medical is a cloud-native software company focused on transforming radiology workflows. The Regulatory Affairs Manager will build a global regulatory system, support teams with regulatory guidance, and lead cross-functional initiatives to ensure compliance with medical device regulations.

Artificial Intelligence (AI)Health CareSoftware

Responsibilities

Partner with leadership and product managers to establish medical device classifications. Execute related plans to obtain required regulatory clearances or approvals in a timely manner

Leverage external regulatory firms to design regulatory strategies and lead internal execution

Determine regulatory requirements for selling and marketing Sirona medical devices globally, including local device classification, registrations, and in-country representation with appropriate partners

Host audits and inspections conducted by U.S. and global regulatory agencies or standards bodies

Collaborate cross-functionally to ensure regulatory requirements, concepts, processes, and objectives are clearly understood by all stakeholders

Manage execution of regulatory affairs plans, including defining progress metrics and implementing escalation processes as needed

Define and execute required regulatory certifications and MDSAP plans

Host internal audits and regulatory inspections in partnership with the VP of RAQA

Work closely with the engineering organization to establish, track, and continuously improve regulatory metrics

Develop deeper regulatory and quality expertise through hands-on experience and mentorship

Represent the VP of RAQA as needed, exercising sound judgment and decision-making (e.g., managing high-volume inquiries or operational decisions)

Maintain a global regulatory watch and advise the business accordingly

Qualification

Medical device regulationsFDA regulationsEU MDRISO 13485Regulatory strategyAudit experienceTraining material developmentProactive mindsetOrganizational skillsCommunication skills