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Regulatory Affairs Specialist - Chemicals

Device Technologies

Job Description

We are seeking a team member who is passionate about chemistries and their important role in the healthcare setting.

You are a deadline driven, high performer who adapts quickly to change and enjoys solving problems and delivering on promises. You are detail focussed, and aware of the bigger picture, understanding the importance of prioritising your focus to meet business and customer needs. You are an exceptional communicator who can explain complex regulatory requirements and processes in non-regulatory terms.   

About us…
We are a large Australian privately owned company that markets and sells high quality capital equipment and medical device consumables. 
At Device Technologies we are motivated by the opportunity our equipment provides to change people’s lives. We have a clear vision to ensure all our people feel valued and respected, can be themselves and can flourish as contributors to the success of Device Technologies and our promise. All applicants will receive consideration for employment without regard to diversity of race, gender, sexual orientation, religion, ethnicity, disability, age and all the other wonderful characteristics that make us different.

The Premarket Team is part of Regulatory Affairs and Quality Assurance (RAQA) and are responsible for ensuring registration and compliance of all therapeutic goods distributed by the company. They work closely with all internal teams to ensure business needs are met, as well as liaising with external government departments, the TGA and AICIS, and over 300 partner manufacturers to ensure the chemical and medical products supplied meet the highest of quality, safety and efficacy standards. Meeting customer and patient needs is always at the forefront of the RAQA team’s activities.
This RA Specialist (Chemicals) role is full-time, based in Belrose on the Northern Beaches of Sydney. 

What you will be doing:
Ensure compliance and permits are in place for Australian and New Zealand safety and regulatory requirements for chemicals products, including AICIS, EPA, HSNO, GHS, and provide training and support to other internal and external teams relating to these requirements.  Ensure TGA, Medsafe and other government or regional regulatory requirements are met for your specific portfolio of Medical Devices, including the preparation and lodgement of regulatory applicationsSolve complex registration and compliance challenges with a focus on delivering business results through collaboration, ownership and innovation. Liaison with internal and external customers, including Vendors, the TGA and Medsafe, AICIS, and the EPA.Ensure accuracy and currency of records and regulatory information held in databases Provide training and support to internal teams in specialised areas of knowledge to continuously improve business and regulatory practicesEnsure accuracy and currency of records and regulatory information held in databases

Skills required:
3+ year experience in Chemicals Compliance in the Australian, New Zealand or equivalent overseas jurisdiction 3+ year experience in Regulatory Affairs of Medical Devices in Australia or a comparable regionPreparation and submission of Class I-IIb medical devices with government agenciesTertiary qualifications in a relevant field (e.g. Chemistry, Science, Medical, or Engineering)Exceptional Communication Skills Problem Solving Business AcumenAttention to detailCustomer Focus
 
Interested? 
In order to apply, please attach your resume (in confidence) along with a cover letter explaining why you believe you meet the listed criteria.  

Please note: 
All applications without a resume attached and direct contact details will not be considered.   

Due to a high volume of applicants, only those successful in making the shortlist will be contacted.
 
NO AGENCIES - THANK YOU