In-Demand Senior regulatory affairs Jobs in Guildford Nsw

Senior Regulatory Affairs Associate
Solventum —North Ryde NSW
- Full-time
- Administrative experience
- Bachelor's degree
- Communication skills
Senior Regulatory Affairs Specialist
AstraZeneca —Macquarie Park NSW
- Full-time
- Hybrid work
- Bachelor's degree
- AI
- Communication skills
12d
Senior Manager Regulatory Affairs
Cencora —North Sydney NSW
- Full-time
- Management
- Bachelor's degree
- No degree
9d
Senior Manager - Governance & Regulatory Affairs
Macquarie Group Limited —Sydney NSW
- Full-time
- Hybrid work
- Financial services
- Communication skills
- Annual leave
- Work from home
2d
Regulatory Affairs Senior Scientist (12 Months Fixed Term Contract)
PepsiCo —Chatswood NSW
- Contract
- English
- Bachelor's degree
Senior Associate, Public Affairs
Teneo —Sydney NSW
- Microsoft Powerpoint
- Microsoft Excel
- Research
Manager - Regulatory Affairs and Engagement
Macquarie Group Limited —Sydney NSW
- Full-time
- Remote
- Management
- Financial services
- Annual leave
- Work from home
Public Affairs and Communications Account Director
Hanbury Strategy —Sydney NSW
- Full-time
- Hybrid work
- Communication skills
- Gym membership
Quick Apply
Senior Associate - External Manufacturing Quality
Reckitt —Sydney NSW
- Bachelor's degree
- Manufacturing
- Communication skills
- Employee assistance program
- Life insurance
10d
Project Administrator [Pristine P&P Pty Ltd]
Pristine P&P Pty Ltd —Haymarket NSW
- $75,000 - $85,000 a year
- Full-time
- ERP systems
- Microsoft Office
- Master's degree
Quick Apply
Senior Manager, Study Site Engagement
Takeda Pharmaceutical —Sydney NSW
- Full-time
- Microsoft Powerpoint
- Microsoft Word
- Microsoft Excel
8d
Head of Government & Regulatory Relations
Link Group —Sydney NSW
- Contract
- Analysis skills
- Financial services
- Communication skills
Manager - Compliance Frameworks and Policies
Bank of Queensland —Sydney NSW
- Full-time
- Financial services
- Communication skills
- Parental leave
- Employee assistance program
Senior Communications Manager ANZ
BI Australia —Sydney NSW
- Full-time
- Bachelor's degree
Senior Clinical Research Manager
Medtronic —Sydney NSW
- Full-time
- Management
- Master's degree
Associate Director / Director, Insolvency, Quality & Risk Management, Financial Advisory
Teneo —Sydney NSW
- Part-time
- Leadership
- Communication skills
- Time management
Risk Governance Senior Analyst / Manager
Macquarie Group Limited —Sydney NSW
- Full-time
- Hybrid work
- Analysis skills
- Financial services
- Communication skills
- Annual leave
- Work from home
14d
Senior Clinical Research Associate
PSI CRO —Sydney NSW
- Full-time
- Hybrid work
- Patient monitoring
- Microsoft Office
- Bachelor's degree
Quick Apply
6d
Account Director (Public Affairs & Communications)
Hanbury Strategy —Sydney NSW
- Hybrid work
- Communication skills
Clinical Specialist - TAVR - AU
Anteris Technologies —Sydney NSW
- $145,000 - $200,000 a year
- Remote
- Nursing
- Anatomy knowledge
- Bachelor's degree
- Annual leave
Quick Apply

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Senior Regulatory Affairs Associate

Solventum -
North Ryde NSW

Apply Now

Job Details

Full-time

Qualifications

Administrative experience
Bachelor's degree
Communication skills

Full Job Description

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description:

Senior Regulatory Affairs Associate for Medical Devices in Sydney, Australia

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue.

We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

We currently have an opening for a Sr. Regulatory Affairs Associate, with below details:

Scope and Responsibilities:

Ensures regulatory compliance of the Health Care Business products for ANZ.
Develops and maintains documentation relevant to assessment of risk to human health and the environment.
Prepares and files regulatory document to Australia and New Zealand Healthcare Authorities for registration.
Responsibilities
Collaborates with cross-functional teams to compile and submit regulatory submissions for medical devices in accordance with local regulations and guidelines.
Supports the development and maintenance of regulatory documentation, including technical files, design dossiers, and quality management system records.
Interacts with regulatory authorities to address inquiries, provides necessary documentation, and resolves any compliance issues.
Stays updated on industry trends, new regulations, and changes in the regulatory landscape, providing valuable insights to the
team.
Performs post market activities to support product compliance.
Reviews Artwork/ Packaging materials supporting compliance and registration of product

Qualifications/Desired Background:

A bachelor's degree in a relevant scientific or health discipline
Strong Data Analytics/Reporting skill set
Demonstrated experience in regulatory affairs within the medical device industry.
Class III Device Application and Conformity Assessment experience
Solid understanding of regulatory frameworks, such as TGA (Therapeutic Goods Administration) and Medsafe.
Strong knowledge of ISO 13485, MDR (Medical Device Regulation), and other applicable standards.
Excellent written and verbal communication skills, with the ability to communicate complex regulatory concepts effectively.
Strong interpersonal skills, with the ability to collaborate and interact with teams both locally and internationally
Critical Thinking skills that inform regulatory strategy.
Meticulous attention to detail and a keen eye for accuracy

Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers.

Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com . Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains.

Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.

Solventum Global Terms of Use and Privacy Statement

Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms.

Please access the linked document by clicking here . Before submitting your application you will be asked to confirm your agreement with the
terms.

Apply Now

Refine Your Search

senior regulatory affairs jobs in guildford nsw

Senior Regulatory Affairs Associate

Senior Regulatory Affairs Specialist

Senior Manager Regulatory Affairs

Senior Manager - Governance & Regulatory Affairs

Regulatory Affairs Senior Scientist (12 Months Fixed Term Contract)

Senior Associate, Public Affairs

Manager - Regulatory Affairs and Engagement

Public Affairs and Communications Account Director

Senior Associate - External Manufacturing Quality

Project Administrator [Pristine P&P Pty Ltd]

Senior Manager, Study Site Engagement

Head of Government & Regulatory Relations

Manager - Compliance Frameworks and Policies

Senior Communications Manager ANZ

Senior Clinical Research Manager

Associate Director / Director, Insolvency, Quality & Risk Management, Financial Advisory

Risk Governance Senior Analyst / Manager

Senior Clinical Research Associate

Account Director (Public Affairs & Communications)

Clinical Specialist - TAVR - AU

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