Pharmaceuticals & Medical Devices (Healthcare & Medical)
Adherium is an international respiratory eHealth company revolutionizing patient medication adherence, remote monitoring, and data management with market-leading respiratory solutions for patients, healthcare workers, and service providers.
Adherium's Hailie sensor technology and cloud-based data platform provides real-time feedback on patients' use of inhaled medication, enabling optimal management of difficult-to-treat and severe asthma and COPD, and reducing direct and indirect healthcare costs.
We are a dynamic, growing company with global teams across New Zealand, Australia, UK, USA, and Thailand.
The Role
The Head of Quality & Regulatory directs and oversees the company quality management, regulatory, and clinical affairs functions to achieve quality and regulatory compliance and market access for intended sales territories.
Ensure that Adherium products meet quality requirements and have access to desired global markets with commercially effective claims and product positioning.
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.
Oversee the implementation of those strategies and plans to ensure outcomes are achieved on time and within budget.
Collaborate and communicate across the company to ensure all relevant departments have input to the development of the quality, regulatory, and clinical strategies, understand the strategies, are trained, and understand their role in contributing to achieving market access through RA/QA compliance.
Oversee and direct the Company's clinical and user studies, including pre-commencement and active programs sponsored both by Adherium and our customers and partners.
Communicate clearly and persuasively to internal stakeholders (regional and global teams, business partners). Deliver good news, issues, and risks with candour and be solutions-focused.
What you'll need to succeed
Extensive experience in a Medical Device company.
Previous experience working with the FDA & TGA.
Possess excellent written, verbal, and communication skills.
Experience managing a team.
Strong relationship builder and communicator with diverse teams.
Ability to engage & influence others to achieve favourable outcomes.
Knowledge of how Medical Device products are marketed and the regulatory impact on promotional literature and activities.
At least 7+ years experience in quality/regulatory in medical device companies.
This is a great opportunity for a driven and innovative person to join a company with a passion for technology that will help make people's lives better. If you think you have the right skills and you want to join a company with a compelling vision and a friendly, capable team – then APPLY NOW.
What You'll Get in Return From Us:
Hybrid work environment - flexibility.
Support with role-aligned professional development.
Share Appreciation Rights for employees.
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