VP of Quality, Regulatory & Clinical Affairs – digital health organisation
Posted 9 December 2021
Our client aims to be the leading digital solution for the management of respiratory disease; integrating devices and data to optimise outcomes for patients, healthcare professionals and payers.
Reporting to the CEO, your key remit will be to strategically direct and oversee the company’s quality management, regulatory, and clinical affairs functions to achieve compliance and market access.
Develop quality, regulatory, and clinical affairs strategies that achieve the commercially required market-access with the optimal balance of cost effectiveness, time to market, and regulatory compliance vs risk.
Collaborate and communicate across the company to ensure all relevant departments have input to the development of the QA/Reg/Clin strategies, understand the strategies, are adequately trained, and understand their role in contributing to achieving market access through RA/QA compliance.
Oversee or manage the Company’s clinical and user trials and home-health programmes, including pre-commencement and active programmes.
Ensure that the Quality Management System (QMS) complies with all applicable standards and regulatory requirements, including ISO13485, the Australian Medical Device Regulations 2002, the European Medical Device Regulations 2017/745 (MDR), and the US Code of Federal Regulations 21 CFR 820.
Ensure that processes needed for the QMS are established, implemented, and maintained, and that the QMS is suitable and effective.
Create the Regulatory Strategy. Develop strategic options for regulatory compliance and approval and/or clearance pathways in target markets.
Minimum of 5 years medical device/electronics/health IT industry experience across global markets.
Quality management or clinical studies experience in a regulated medical device industry. Experience in more than one of these areas highly regarded.
Familiarity with requirements and processes of ISO 13485 and FDA QSR quality systems.
Practical knowledge of design controls, risk management, process validation, quality system software validation, production and change controls as they apply to a regulated software and electronics developer and manufacturer.
Familiarity with software, electronics, and wireless communications design activity.
Familiarity with information security management system and data privacy requirements.
Experience working with teams based in multiple global locations and time zones.
Outstanding organisational and problem-solving skills essential, required for management of multiple projects.
You will join one of Australia’s most exciting expanding health technology companies. Our client is open to reviewing candidates across a range of experiences for this role. Quality Management expertise would be highly regarded with exposure across additional competencies also preferred.
For this permanent and exciting opportunity please email your cover letter & CV to firstname.lastname@example.org. Confidential enquiries to Marilyn Jones on 1300 0 MEXEC.