Current jobs related to Global Regulatory Leader - Sydney, New South Wales - beBeeRegulatory
-
Global Regulatory Strategist
1 week ago
Sydney, New South Wales, Australia beBeeSpecialist Full time $120,000 - $250,000Regulatory Strategy and Advisory ExpertiseThe Legal and Compliance team comprises lawyers, compliance specialists, and other professionals worldwide.The team offers diverse expertise in commercial law, regulatory compliance, mergers and acquisitions, corporate governance, privacy, employment, and international legal experience to support a large workforce...
-
Strategic Regulatory Product Leader
2 weeks ago
Sydney, New South Wales, Australia beBeeRegulatory Full time $188,980 - $243,599Job Title: Strategic Regulatory Product LeaderThis is a key role for an experienced Regulatory Affairs professional who will oversee regulatory execution for products manufactured under the legal entity.The successful candidate will lead a team responsible for shaping and delivering global regulatory strategies that span concept through launch and ensuring...
-
Global Regulatory Specialist
2 weeks ago
Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $180,000Competition Lawyer PositionWe are seeking a qualified professional to fill the role of Competition Lawyer. The successful candidate will work with leading partners advising domestic and international clients on a broad spectrum of competition and regulatory matters.About the RoleThis is an excellent opportunity to gain exposure to global transactions and...
-
Global Regulatory Compliance Specialist
2 weeks ago
Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $90,000 - $120,000Regulatory Affairs ProfessionalThe primary objective of this role is to provide expert guidance and support with respect to the regulatory environment, at all stages of the life cycle of our products.The Regulatory Affairs team ensures that management systems are established to enable us to comply with, and readily display compliance with, multiple...
-
Senior Global Regulatory Affairs Specialist
2 weeks ago
Sydney, New South Wales, Australia beBeeRegulatory Full time $120,000 - $150,000Global Regulatory Affairs LeadThis is an exciting opportunity to join a global team as a Senior Specialist in Regulatory Affairs. You will be responsible for authoring and reviewing global regulatory submissions, guiding change assessments, and mentoring team members on the application of global regulations.Key Responsibilities:Author and review global...
-
Global Regulatory Affairs Expert
2 weeks ago
Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $100,943 - $143,956We are seeking a highly skilled Regulatory Affairs professional to drive compliance and strategy in our global operations.This role requires expertise in regulatory affairs, strategic planning, communication, and collaboration with regional and corporate teams.Key responsibilities include:Developing and implementing regulatory strategies to ensure compliance...
-
Global Regulatory Affairs Specialist
1 week ago
Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000Regulatory Affairs ExpertiseWe are seeking a highly skilled and experienced regulatory affairs professional to lead the development of our product portfolio in Sydney.Key Responsibilities:Develop and implement strategic plans for regulatory submissions across Australia and New Zealand.Collaborate with global, regional and local colleagues to ensure timely...
-
Sydney, New South Wales, Australia beBeeSpecialist Full time $170,000 - $200,000Global Competition Law Specialist OpportunityJob Summary: We are seeking an experienced Global Competition Law Specialist to join our top-ranked global competition law team.2–5 years' experience in regulatory and litigation exposure is essential.You will work alongside leading partners advising domestic and international clients across various competition...
-
Global Regulatory Compliance Specialist
2 weeks ago
Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $85,000 - $115,000Job DescriptionAs a Regulatory Affairs Assistant, you will play a critical role in facilitating compliance and ensuring the smooth operation of our global pharmaceutical company. You will be responsible for reviewing, compiling, and submitting registration dossiers and data packages within agreed-upon timeframes. This includes managing assigned tasks,...
-
Global Regulatory Compliance Expert
2 weeks ago
Sydney, New South Wales, Australia beBeeConflict Full time $162,700 - $216,600Job Description:">The Conflicts Team is responsible for advising the Firm globally on regulatory compliance issues, including conflicts of interest, financial crime, and sanctions.
Global Regulatory Leader
3 weeks ago
About Us
We're a leading innovator in health technologies, transforming millions of lives daily. From respiratory care to cloud-based software solutions, our devices span the globe and connect patients, providers, and data to improve healthcare outcomes.
Our Regulatory Affairs team 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
You will oversee regulatory execution for products manufactured under our 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 Responsibilities
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.
Required Skills and Qualifications
Bachelor's degree 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.
Benefits
We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If you're excited to shape the next chapter of regulatory leadership, join us.
,