Head of Product Development - Medical Device Utilise your medical device experience to make a real difference to the millions of people relying on daily inhaled therapies to manage their respiratory conditions.
About the company: Headquartered in Perth Western Australia, Inspiring is a medical device company looking to revolutionise the delivery of inhaled therapies with our patented platform technology.
It is an exciting time to join the company as we prepare to bring our lead program, a respiratory medical device through regulatory submission to market.
About the role: We are seeking a highly motivated and experienced individual who has had end to end experience managing product development projects within the medical device industry, with a strong background in medical device development, usability/human factors, and regulatory affairs.
You will play a pivotal role in ensuring successful development and regulatory approval of our medical devices.
Reporting to the CEO, this role is critical for the company and will:
Lead our key program through product development phases all the way to regulatory submission including manufacturing, testing, usability and regulatory requirements.
Ensure program alignment with timelines, budgets, and strategic objectives.
Closely liaise and coordinate internal team members, third party development, contractors and subcontractors.
Coordinate regulatory requirements, including 510(k) submissions with our regulatory consultant, and liaise with FDA and other regulatory bodies as required.
Monitor and report on project progress, proactively identifying and resolving issues and bottlenecks.
Monitor quality assurance activities to ensure that the final product meets the requirements.
Proven track record in leading all stages of product development through to regulatory submission of medical device, ideally through FDA 510K pathway (or similar regulatory pathway).
Experience in medical device development requirements and stages (respiratory ideal).
Experience in medical device manufacturing, regulatory pathways and usability/human factors studies.
Systems Engineering experience with technical nous and ability to translate technical concepts into easily understandable messages.
Experience with application of ISO 13485 and ISO 14971-Risk Management.
Demonstrated leadership skills with the ability to take ownership.
Qualifications: Bachelor's degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
7+ years experience in Medical Device development.
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