Resmed | Senior Specialist, Regulatory Affairs

vor 2 Wochen

Sydney, Österreich Tideri Jobbörse Vollzeit

Let's talk about the team:
The Global Product Team is a dynamic, cross-functional group that drives the development and innovation of our products across multiple regions, with a primary focus within our Sydney and Singapore offices.
This team is responsible for overseeing the entire product lifecycle, from ideation through development, and ensuring that both hardware and software components work seamlessly together to deliver exceptional products to our customers.

Let's talk about the role:
The Regulatory Affairs Senior Specialist is responsible for ensuring market access and regulatory compliance for hardware and software medical devices, including both medical and non-medical software systems.
This role involves executing regulatory strategies across the total product lifecycle, working closely with cross-functional teams such as Product Development, Engineering, Data Science, Quality, and Commercial to meet global regulatory requirements.
The Senior Specialist will ensure continued regulatory compliance and drive product submissions in accordance with relevant local and international standards, including EU MDR, FDA, and regulations for Software as a Medical Device (SaMD) and AIML.

Key Responsibilities and Accountabilities
Develop and execute regulatory strategies and timelines for hardware and software medical devices (including SaMD and AIML-enabled devices) to meet regulatory requirements for global markets.
Prepare and manage submissions to regulatory bodies such as the FDA, EU Notified Bodies ensuring compliance with U.S. premarket device submissions, CE marking, EU MDR, and other global regulations.
Maintain regulatory submissions and premarket registrations, ensuring that all necessary documentation is complete and up to date.
Participate in cross-functional teams to provide regulatory guidance throughout the product development lifecycle, ensuring that hardware and software product designs meet regulatory and safety standards.
Work closely with Quality Assurance to integrate regulatory requirements into the Quality Management System (QMS) for software and AIML-enabled products.
Ensure continued compliance of existing hardware and software products in global markets by assessing and managing design changes and non-significant change determinations.
Provide guidance for clinical trials related to regulatory approval and ensure that trials align with global regulatory expectations.
Stay up to date on regulatory developments and emerging global standards for medical devices, software, and artificial intelligence (AI/ML) systems.
Help assess the impact of new regulations on product development and submission processes.
Attend relevant conferences, seminars, and other professional events to remain informed about regulatory changes.
Let's talk about you
Bachelor's degree in a technical field such as Engineering, Life Sciences, or a related discipline (Software background preferred).
5+ years of experience in regulatory affairs within the medical device industry.
Demonstrated experience with US premarket device submissions (e.g., 510(k)), EU MDR submissions, and working knowledge of FDA, ISO 13485, and IEC 62304.
Experience with digital health technologies, SaMD, AI/ML-based products, and knowledge of applicable global regulations.
Experience with managing the regulatory lifecycle for both hardware and software-based medical devices, including navigating post-market compliance.
Skills:
Strong project management, organizational, and multitasking skills.
Ability to work independently and collaboratively with cross-functional teams.
Excellent communication and interpersonal skills, with the ability to effectively influence and negotiate.
High attention to detail and strong analytical thinking, particularly in interpreting regulatory guidelines and standards.
Preferred experience in both hardware and software product development environments.
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