In-Demand Regulatory specialist Jobs in New South Wales

Senior Specialist, Regulatory Affairs (Americas & ANZ)
ResMed —Sydney NSW
- Full-time
- Hybrid work
- Engineering
- Bachelor's degree
- No degree
12d
Trust & Safety Compliance Specialist
TikTok USDS JV —Sydney NSW
- Hybrid work
- Writing skills
- Education
- Bachelor's degree
Claims Knowledge & Communications Specialist
TAL —Sydney NSW
- Full-time
- Hybrid work
- Communication skills
Quick Apply
Regulatory Interpretations Specialist
Macquarie Group Limited —Sydney NSW
- Full-time
- Hybrid work
- Analysis skills
- Annual leave
- Work from home
Quality & Compliance Auditor
WeCare Wellness Group —Hurstville NSW
- $80,000 - $100,000 a year
- Full-time
- In-person
Quick Apply
Senior Regulatory Affairs Specialist
AstraZeneca —Macquarie Park NSW
- Full-time
- Hybrid work
- Bachelor's degree
- AI
- Communication skills
14d
Consultant II
Fulcrum —Sydney NSW
- $209,440 a year
- Full-time
- Doctoral degree
- Research
- Master's degree
- Annual leave
- Work from home
Quick Apply
3d
Regulatory Engagement Specialist
BaptistCare —Norwest NSW
- Full-time
- Hybrid work
- Analysis skills
- Organisational skills
- Leadership
3d
Site Navigator II (Study Start-up Specialist) - Sydney or Melbourne
Fortrea —Sydney NSW
- Full-time
- Research
- Senior Secondary Certificate of Education
- Bachelor's degree
Regulatory and Study Start Up Clinical Trials
Chris O’Brien Lifehouse —Camperdown NSW
- Full-time
- Organisational skills
- Communication skills
- Negotiation
- Employee assistance program
8d
Trust & Safety Compliance Specialist (Swing Shift)
TikTok USDS JV —Sydney NSW
- Hybrid work
- Writing skills
- Education
- Bachelor's degree
Software Quality & Validation Specialist
MoleMap Australia & New Zealand —Mascot NSW
- Hybrid work
- Management
- Computer Science
- APIs
Start-up Associate (Clinical Trial Associate) - Sydney
Fortrea —Sydney NSW
- Full-time
- Office
- Bachelor's degree
8d
Course Quality & Self-Assurance Specialist
TAFE NSW —Inner West NSW
- $139,508 - $142,962 a year
- Part-time
7d
GHD Graduate Program – Secretariat & Registry - Sydney
GHD —Sydney NSW
- Finance
- Business
- Communication skills
Bogan Shire Council - EOI - Expression of Interest
Bogan Shire Council —Nyngan NSW
- Full-time
- Employee assistance program
Quick Apply
Curriculum Systems Specialist
TAFE NSW —New South Wales
- $128,284 - $141,600 a year
- Full-time
- Management
2d
Operations Specialist, Index Committee - S&P Dow Jones Indices
S&P Global —Sydney NSW
- Management
- Financial services
- AI
- Health insurance
- Annual leave
Asset Management Specialist
KBR —Sydney NSW
- Full-time
- Engineering
- Parental leave
Quality and Compliance Specialist
Anglicare —Macquarie Park NSW
- Full-time
- Analysis skills
- Communication skills
- Employee assistance program
- Gym membership

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Senior Specialist, Regulatory Affairs (Americas & ANZ)

ResMed -
Sydney NSW

Apply Now

Job Details

Full-time
12 days ago

Qualifications

Engineering
Bachelor's degree
Risk management
Communication skills

Full Job Description

Team: Regulatory Affairs – Americas & ANZ

Reporting To: Director, Regulatory Affairs – Americas & ANZ

Direct Reports: No

Location: Sydney (Hybrid or Remote)

About ResMed

At ResMed, 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 ResMed 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: QARA – Global Regulatory Affairs

The RA Global team is located at various offices around the world and is responsible for compliance wit h multiple regulatory frameworks as it relates to design, development and manufacture of products as well as services which meet our customer’s requirements.

Based in Australia, you will manage and execute the planning, development and implementation of RA strategies for new and existing business channels in ANZ and the Americas (Australia, New Zealand, North and South America). You will also provide regional regulatory support to operational activities for ANZ including label review and submissions. You will be part of and collaborate closely with other global and regional RA teams.

Position Summary

As a Regulatory Affairs Specialist – Americas & ANZ, you will develop and execute innovative regulatory strategies for products and services. You will lead regulatory change assessments in your region. This role requires the ability to look over a broad portfolio of products, many of which may not be medical devices products in all markets, understanding the nuance of such differences and providing the business with actionable strategies to support growth.

You will collaborate across Regulatory Affairs, Quality, Product Marketing, Revenue and Supply Chain. You’ll also serve as a mentor to peers, ensuring technical consistency, clarity, and excellence in regulatory execution.

Let’s talk about Responsibilities

Participate in regional cross functional teams, by providing regulatory strategy, timelines, and deliverables; working closely with product development, clinical, marketing, and commercial functions to assure appropriate requirements are defined for the specific device/channel, including claims and target patient population within each market.

Manage the preparation and compilation (i.e., submission document creation, legalization/apostille) for premarket registrations for ANZ and Americas , as well as continuance of regulatory compliance (particularly post market) of existing ResMed products, including software as a medical device.

Control and maintain regulatory records, including, but not limited to: submission documentation, tracking of part number approval per country, establishment registrations, import for export, etc.

Support initiatives related to regional entity creations (including eCommerce).

Ensure timely, professional, and proactive communications with: (1) internal customers to ensure transparency of the regulatory strategic plans, updates/changes, and impact to projected timeframes; (2) external customers to ensure applications are submitted to local health authorities consistent with regulatory strategic plan; and (3) health agencies/consultants to ensure adequate and appropriate information is provided as well as driving submissions to approval as effectively as possible.

Monitor and maintain high level of awareness on external standards (technical publications, articles, and abstracts) that will influence our business through internal and external networks.

Accurately and timely share and recommended solutions to the global regulatory network on any potentially significant regulation or standard changes that will impact the business.

Demonstrate continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including ANZ and Americas country specific regulations, and policies applying to medical devices, global registration, technical writing, etc.

Let’s talk about Qualifications and Experience

Bachelor’s degree in a Life Sciences , Engineering , or related discipline. Equivalent experience will also be considered.

6 to 8 years’ regulatory experience in handling regulatory work for medical devices or pharmaceuticals specifically in the ANZ region, experience with other regulated markets a plus.

Desirable experience with entity licensing for import/distribution of health products.

Strong interpersonal communication skills in English

Knowledge of ISO 13485, ISO 14971, design control requirements, post-market surveillance, and risk management principles.

Experience with software-based medical devices, digital health technologies, or connected healthcare products.

Regulatory Affairs Certification (RAC) or progress toward RAC certification preferred.

Experience working in matrixed global organizations and influencing stakeholders without direct authority

Creative, detail oriented, resourceful, highly organized, and able to prioritize workload and work independently

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 now! We commit to respond to every applicant.

Apply Now

Refine Your Search

regulatory specialist jobs in new south wales

Senior Specialist, Regulatory Affairs (Americas & ANZ)

Trust & Safety Compliance Specialist

Claims Knowledge & Communications Specialist

Regulatory Interpretations Specialist

Quality & Compliance Auditor

Senior Regulatory Affairs Specialist

Consultant II

Regulatory Engagement Specialist

Site Navigator II (Study Start-up Specialist) - Sydney or Melbourne

Regulatory and Study Start Up Clinical Trials

Trust & Safety Compliance Specialist (Swing Shift)

Software Quality & Validation Specialist

Start-up Associate (Clinical Trial Associate) - Sydney

Course Quality & Self-Assurance Specialist

GHD Graduate Program – Secretariat & Registry - Sydney

Bogan Shire Council - EOI - Expression of Interest

Curriculum Systems Specialist

Operations Specialist, Index Committee - S&P Dow Jones Indices

Asset Management Specialist

Quality and Compliance Specialist

I want to receive the latest job alert for regulatory specialist in new south wales

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