Head of Quality and Regulatory
6 days ago
Adherium is a leading international respiratory e Health company that is revolutionizing patient medication adherence, remote monitoring, and data management with market-leading respiratory solutions for patients, healthcare workers, and service providers.
We are a dynamic, growing company with global teams across New Zealand, Australia, UK, USA, and Thailand.
The RoleThe Head of Quality and Regulatory directs and oversees the company's quality management, regulatory, and clinical affairs functions to achieve quality and regulatory compliance and market access for intended sales territories.
Key Responsibilities:
- 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.
Requirements:
- 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.
We offer a hybrid work environment, support with role-aligned professional development, and Share Appreciation Rights for employees.
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