Hot Jobs

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 there responsibilities
• Work with internal and external stakeholders to manage the compliance initiatives of new and existing markets across the United States, Europe, Australia ect.
• Manage expectations of requirements to internal and external customers building positive relationships building 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 orientated 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 jaymin.southee@h2r.co.nz or apply today.