Regulatory Manager

H2R Technology is partnering with Volpara Health to recruit a Regulatory Manager.
Volpara's Mission is to reduce the mortality and cost of breast cancer by providing clinically validated software that underpins personalized, high-quality breast cancer screening.
Volpara's screening technology enables radiologists to quantify breast tissue with precision and helps technologists produce mammograms with optimal image quality, positioning, compression, and dose.
Role Overview: The Regulatory Manager is responsible for ensuring Volpara's medical software products meet the regulatory requirements for markets sold into, as evidenced by no major non-conformities related to the regulatory function. When this role is successful there will be no regulatory related major non-conformities and minimal minor non-conformities reported as part of the external medical device audits and employees are aware of and understand how regulatory requirements apply to them.
Responsibilities: Lead pre and post market regulatory requirement and compliance initiatives.
Collaborate with software product-based teams to ensure the product is compliant and teams are aware of their responsibilities.
Work with internal and external stakeholders to manage the compliance initiatives of new and existing markets across the United States, Europe, Australia, etc.
Manage expectations of requirements to internal and external customers, building positive relationships based on trust and respect.
Lead process analysis to understand what is needed to get things done, separating tasks and people to create effective workflow.
Experience: Must have experience within a regulatory function within the medical industry.
Ideally have experience within software and product-oriented teams.
Familiar with regulatory standards in relation to health in various international markets.
Working knowledge of risk-based frameworks.
Excellent written and verbal communication skills including presenting and writing reports for an executive level audience.
For more information, contact Jaymin Southee on 044999471 or ****** or apply today.

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