Regulatory Associate

3 months ago

North Ryde, Australia EBOS MedTech Full time

Opportunity to grow your career and make a difference in the lives of others
- Great company to grow your career and make a difference in the lives of others
- Role can be based in Sydney, Brisbane or Melbourne - we are flexible

**About us**:
LifeHealthcare, a company of EBOS Med Tech, believe Australian and New Zealand healthcare professionals and patients should have access to world-leading medical devices, whilst ensuring long-term economic sustainability within the healthcare system. As a leading independent distributor of medical technology, we bring innovative medical solutions to healthcare professionals by partnering with world leading companies who share our vision for innovation and making a real difference to people’s lives.

At LifeHealthcare, our passion is health, and our purpose is helping to make life better for others. As an organisation, we are guided by a set of values - Accountable, Agile, Authentic and Customer Centric that define our character and culture. We encourage and support employees to live our values every day, whilst offering a range of benefits including health insurance discounts, career opportunities across EBOS Med Tech, generous parental leave, employee referral programs, opportunity to purchase leave, volunteer leave, recharge days and financial rewards for individual and company performance.

**The Opportunity**:
If coordinating new product registration with the TGA & Medsafe, whilst meeting regulatory requirements of a diverse portfolio and playing a key role in giving patients access to innovative technologies drives you to succeed, then our Regulatory Affairs Associate role may be just what you’re looking for Working within a small and supportive team and part of the broader Marketing group, you will be reporting to the Market Access Manager. This is an appealing opportunity for someone interested in building a strong career in Medical Device Regulatory Affairs.

**You’ll stand out from the crowd if you**:

- Understand legislation governing regulation of medical devices in Australia & New Zealand
- Have knowledge of requirements for ongoing registration of products and experience managing recall processes
- Have an excellent ability to grasp new concepts quickly and to assimilate data from a range of scientific areas.
- Possess excellent communication skills, both written and verbal
- Demonstrate a can-do attitude and hands on work style.

**You’ll be responsible for**:

- Coordination & maintenance of LifeHealthcare’s pre and post market Regulatory requirements to comply with Australian TGA and New Zealand Medsafe guidelines and other relevant legislative requirements
- Providing regulatory bodies with required reports/reviews (for example, annual reporting, post market reviews & general enquiries)
- Informing and prepare the business for upcoming legislative changes which may have a commercial impact

**And to be successful we think you’ll need**:

- At least 2 to 3 years’ experience preferably in regulatory affairs in medical device industry, and
- A degree in a related scientific or engineering field will be highly regarded

LifeHealthcare is a company of EBOS Med Tech, which also includes an allograft manufacturing (Australian Biotechnologies), an Aesthetics business (Cryomed) and a South-East Asian distribution business (Transmedic). The mission of EBOS Medical Technology is to provide life-changing medical solutions to patients across Asia-Pacific. We have over 1,000 employees in the division, with exposure across 9 different countries. This gives us the opportunity to impact a greater number of patients and provide employees with a richer career experience through exposure to various market and therapeutic areas of medical technology.

If this all sounds like something you want to be a part of, **APPLY** now and watch your career grow as you select the footprint to influence access to the best medical technology for our patients.
- *No agencies please, we have this one covered*_

  • Regulatory Affairs Associate

    3 months ago

    North Ryde, Australia Indigeco Pty Ltd Full time

    12 month contract - $50 per hour plus super - North Ryde Location /WFH Our client is large multi - national pharmaceutical company, they are currently looking for a Regulatory Affairs Associate to join their reputable team. They are located in North Ryde with flexibility to work remotely. **Day to day activities include**: - Co-ordination and submission...

  • Regulatory Affairs Associate

    4 months ago

    Ryde, Australia Pettit Pharma & Device Search Full time

    Do you have Class III Device Application & Conformity Assessment experience? - Be your best with unique resources & high-quality benefits - Maquarie Park location, parking on-site, hybrid office & home work THE COMPANY YOU WOULD BE JOINING - Make a difference in the world at this medical device organisation with a global focus. - Multi-national...

  • Regulatory Affairs Associate

    3 months ago

    North Ryde, Australia 3M Full time

    **Job Description**: **Responsibilities**: 1.) Ensure 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. Performs post market activities and reviews Advertisisng collateral for compliance. Prepares and files regulatory document to...

  • Clinical Trial Start Up and Regulatory Associate

    4 months ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL Seeking a Start up Associate to provide study start-up and regulatory support for sponsored Phase I - IV clinical trial projects THE ROLE- Salary Package: From $76,908 to $87,443 p.a. (HEW Level 5), plus 17% employer's superannuation and annual leave loading.- Appointment Type: Full time, fixed term position for 2 years.- Location: Macquarie...

  • Senior Regulatory Affairs Associate

    4 days ago

    North Sydney, Australia Novo Nordisk AS Full time

    Are you passionate about regulatory affairs? Do you want to play a key role in ensuring the availability of life-changing medicines? If so, we invite you to join our team as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania. Read more and apply today for a life-changing career! About the department You will be part of the Clinical, Medical,...

  • Senior Regulatory Affairs Associate

    4 days ago

    North Sydney, Australia Novo Nordisk Pharmaceuticals Full time

    Are you passionate about regulatory affairs? Do you want to play a key role in ensuring the availability of life-changing medicines? If so, we invite you to join our team as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania. Read more and apply today for a life-changing career! About the departmentYou will be part of the Clinical, Medical,...

  • Senior Regulatory Affairs Associate

    5 days ago

    North Sydney, Australia Novo Nordisk Full time

    The position As a Senior Regulatory Affairs Associate, you will: Lead regulatory affairs activities for assigned products in Australia and New Zealand, ensuring compliance while developing strategies to assist product development, registration, and commercialisation. Manage the preparation, compilation, and timely submission of accurate regulatory...

  • Senior Regulatory Affairs Associate

    5 days ago

    North Sydney, Australia Novo Nordisk Full time

     Are you passionate about regulatory affairs? Do you want to play a key role in ensuring the availability of life-changing medicines? If so, we invite you to join our team as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania. Read more and apply today for a life-changing career! About the departmentYou will be part of the Clinical, Medical,...

  • Clinical Trials Start Up

    4 months ago

    North Ryde, Australia Macquarie University Full time

    PRIMARY DETAIL - Salary Package: From $115,030 to $127,995 p.a. (HEW Level 8), plus 17% employer's superannuation and annual leave loading - Appointment Type: Full time, continuing (permanent) - 35 hour working week with opportunities for flexible working arrangements - Macquarie University (Wallumattagal Campus, North Ryde) location THE ROLE We are...

  • Student Compliance Officer

    2 weeks ago

    Ryde, Australia Beaumont People Full time

    About the RoleWe are partnering with a leading education institution to seek a highly skilled Student Compliance Officer to join their team. As a key member of the compliance administration team, you will play a vital role in ensuring the institution's compliance with regulatory frameworks and maintaining the highest standards of student experience.Key...

  • Clinical Research Associate I

    3 weeks ago

    North Ryde, New South Wales, Australia Parexel Full time

    Job SummaryParexel is seeking a highly skilled Clinical Research Associate I to join our team. As a Clinical Research Associate I, you will be responsible for managing clinical sites, ensuring compliance with regulatory requirements, and providing exceptional customer service to our clients.Key ResponsibilitiesSite Management: Act as Parexel's direct point...

  • Regulatory Affairs Specialist

    5 days ago

    North Sydney Council, Australia Novo Nordisk AS Full time

    Are you passionate about regulatory affairs and eager to contribute to the development of life-changing medicines? We invite you to explore a career opportunity as a Senior Regulatory Affairs Associate at Novo Nordisk Oceania.About the DepartmentYou will be part of the Clinical, Medical, Regulatory (CMR) Oceania team, reporting directly to the Senior...

  • Site Contracts Associate I

    1 week ago

    North Ryde, New South Wales, Australia Parexel Full time

    About the RoleParexel is seeking a highly skilled Site Contracts Associate I to join our team. As a key member of our site contracting team, you will be responsible for negotiating and finalizing site contracts, ensuring compliance with regulatory requirements, and maintaining positive relationships with clinical trial sites.Key ResponsibilitiesDraft,...

  • Clinical Research Associate I

    2 weeks ago

    North Ryde, New South Wales, Australia Isatis Business Solutions Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate I to join our team at Isatis Business Solutions. As a Clinical Research Associate I, you will be responsible for managing clinical trials from site identification to close-out, ensuring timely and accurate completion of project goals and maintaining compliance with ICH-GCP and applicable...

  • Site Contracts Associate I

    5 days ago

    North Ryde, New South Wales, Australia Parexel Full time

    Job SummaryParexel is seeking a highly skilled Site Contracts Associate I to join our team. As a key member of our site contracting team, you will be responsible for negotiating and finalizing site contracts, ensuring compliance with regulatory requirements, and maintaining positive relationships with clinical trial sites.Key ResponsibilitiesDraft, review,...

  • Senior Regulatory Affairs Specialist

    5 days ago

    North Sydney Council, Australia Novo Nordisk Full time

    Job Title: Senior Regulatory Affairs AssociateJob Summary:We are seeking a highly skilled Senior Regulatory Affairs Associate to join our team at Novo Nordisk. As a key member of our regulatory affairs team, you will be responsible for leading regulatory activities for assigned products in Australia and New Zealand, ensuring compliance with regulatory...

  • Regulatory Affairs Director

    2 weeks ago

    North Sydney Council, Australia MLC Limited Full time

    About the RoleWe are seeking an experienced Regulatory Affairs Manager to join our team at MLC Limited. As a key member of our Business Enablement team, you will play a critical role in supporting and managing our engagement with regulators to ensure cohesion in our regulatory narrative and build our reputation as a reliable and high-integrity participant in...

  • Regulatory Affairs Specialist

    2 weeks ago

    North Sydney Council, Australia MLC Limited Full time

    About the RoleWe are seeking an experienced Regulatory Affairs Manager to join our team at MLC Limited. As a key member of our Business Enablement team, you will play a critical role in supporting and managing our engagement with regulators to ensure cohesion in our regulatory narrative and build our reputation as a reliable and high-integrity participant in...

  • Regulatory Affairs Director

    3 weeks ago

    North Sydney Council, Australia MLC Limited Full time

    About the RoleWe are seeking an experienced Regulatory Affairs Manager to join our team at MLC Limited. As a key member of our Business Enablement team, you will play a critical role in supporting and managing our engagement with regulators to ensure cohesion in our regulatory narrative and build our reputation as a reliable and high-integrity participant in...

  • Regulatory Affairs Specialist

    4 days ago

    North Sydney Council, Australia MLC Limited Full time

    About the RoleWe are seeking an experienced Regulatory Affairs Manager to join our team at MLC Limited. As a key member of our Business Enablement team, you will play a critical role in supporting and managing our engagement with regulators to ensure cohesion in our regulatory narrative and build our reputation as a reliable and high-integrity participant in...