Manager, Regulatory Product Strategy

Manager, Regulatory Product Strategy & Delivery page is loaded Manager, Regulatory Product Strategy & Delivery Apply locations Sydney, NSW, Australia time type Full time posted on Posted Yesterday job requisition id JR_043228 About Res Med At Res Med, we pioneer innovative health technologies that transform millions of lives daily.
From connected respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes.
We are proud to lead in the medical device space, where quality, compliance, and patient trust are at the heart of our innovation.
Regulatory Affairs (RA) at Res Med is central to ensuring timely and compliant access to global markets.
We work across more than 140 countries to deliver safe and effective innovations that improve quality of life.
With global reach, deep technical knowledge, and strong regulatory partnerships, we lead with integrity and clarity to shape the future of health technology.
Team Overview : Regulatory Product Strategy & Delivery (RPSD)The Sydney RPSD team is responsible for Regulatory Affairs leadership for product development projects where Sydney is the legal manufacturer.
This includes both New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) projects across masks, therapy devices, and their accessories.
Operating as a vertical team within the broader RPSD function, the Sydney team collaborates with global stakeholders to define and execute regulatory strategies, deliver submission-ready documentation, and enable cross-regional compliance.
This role leads a team of regulatory professionals and works closely with engineering, project management, quality, and global RA partners.
Position Summary Manager, Regulatory Product Strategy & Delivery – Sydney, you will oversee regulatory execution for products manufactured under the Res Med Sydney legal entity.
You'll lead a team responsible for shaping and delivering global regulatory strategies that span concept through launch and ensure successful navigation of global regulatory pathways.
You will be accountable for team performance, resource allocation, regulatory input into cross-functional design activities, and timely submissions across markets.
Key Responsibilities1.
Strategic & Operational Leadership Lead RA strategy and delivery for NPI projects owned by Sydney.
PLE projects owned by the Sydney and Singapore legal manufacturer (e.g., masks, devices, accessories).
Define regulatory pathways and ensure submission planning aligns with market access timelines and business needs.
Guide the development of design input requirements, verification strategies, and risk documentation that meet global regulatory expectations (e.g., 510(k), CE Mark, TGA, MDSAP).
Escalate risks, resource constraints, or submission delays proactively and constructively, in line with the RA escalation model.2.
Cross-Functional Collaboration Support the team and be the RA representative on product XFTs originating from Sydney.
Drive alignment with key functions such as systems engineering, quality, project management, operations, clinical, and marketing.
Ensure early RA input and engagement during design reviews, change planning, and design control phases.3.
Regulatory Strategy & Submission Oversight Oversee the development and delivery of high-quality regulatory submissions globally, including US FDA, EU MDR, TGA, and other priority markets.
Review and approve key submission components and assessments, including Design Change Assessments (DCAs), risk-benefit documentation, and labelling claims.
Ensure documentation is submission-ready and aligned with Res Med's quality system, global templates, and timelines.4.
People Leadership & Team Development Lead and coach a team of regulatory professionals, supporting career development, onboarding, and performance management.
Foster a high-trust, inclusive culture that emphasizes accountability, regulatory excellence, and continuous learning.
Support Individual Development Plans, mentoring structures, and knowledge sharing within the team and the broader RA function.5.
Process Excellence & System Stewardship Drive improvements to regulatory workflows, including Jira tracking, RIMSYS submissions, and Confluence knowledge management.
Ensure the team uses consistent processes, applies global templates, and adheres to design control and submission SOPs.
Collaborate with the Regulatory Foundations and Digitalization teams to enhance submission logistics, tools, and dashboards.
Qualifications & Experience Required Bachelor's degree (or higher) in biomedical engineering, life sciences, regulatory affairs, or a related discipline.6+ years in Regulatory Affairs, with 2+ years in a leadership or mentoring capacity.
Proven experience supporting device submissions (e.g., FDA 510(k), CE MDR, TGA ARTG).
Excellent knowledge of ISO 13485, ISO 14971, 21 CFR 820, and other applicable standards.
Experience working on design and development teams under design control processes.
Strong organizational and time management skills; ability to lead multiple concurrent priorities.
Clear, structured communicator with experience influencing cross-functional partners and regulatory authorities.
Preferred Prior experience leading RA strategy for a legal manufacturer or global product line.
Experience with Jira, Confluence, and RIMSYS (or equivalent regulatory systems).
Familiarity with digital health components (e.g., connectivity, software in devices).
Project management certification or training.
Who You Are You are a strategic operator and a team builder—a person who thrives on connecting the dots between business goals, product innovation, and regulatory pathways.
You have deep RA knowledge and a practical sense for how to lead and deliver in cross-functional environments.
You bring confidence and clarity to complex regulatory decisions, and you create space for others to grow while maintaining a high bar for execution and integrity.
You're excited to shape the next chapter of regulatory leadership at Res Med.
Joining us is more than saying "yes" to making the world a healthier place.
It's discovering a career that's challenging, supportive and inspiring.
Where a culture driven by excellence helps you not only meet your goals, but also create new ones.
We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.
If this sounds like the workplace for you, apply nowJ-18808-Ljbffr
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