Regulatory Affairs Specialist
vor 3 Wochen
ABOUT THE ROLE We are seeking an enthusiastic and skilled regulatory specialist to join our Australia and New Zealand (ANZ) Regulatory Affairs team.
This role offers a great opportunity with a global medical device leader to further develop your regulatory skills across a broad range of therapies and technologies.
The successful candidate will be responsible for the preparation of regulatory submissions to TGA and MedSafe to ensure timely submissions, manage existing licences, and maintain compliance to ANZ regulations.
This is a key role in the organisation ensuring physicians and patients have access to the latest medical technologies to enable optimal patient outcomes.
WHAT WILL YOU BE RESPONSIBLE FOR? Regulatory Knowledge and Application Determine and maintain sound regulatory strategies for market entry in ANZ.
This includes identifying issues early in the planning process that could impact product submission and/or launch.Compile, prepare, review, and submit regulatory dossiers to regulatory authorities.Manage changes to existing products to ensure continued compliance to regulations and supply continuity.Maintain up-to-date knowledge of regulatory requirements and changes in ANZ.Liaise with regulatory authorities and negotiate submission details.Collaborate with cross-functional teams to support product commercialization in ANZ.Support the review and approval of promotional and advertising materials to ensure compliance with the regulations and the MTAA industry advertising code.Maintain regulatory and quality records up to date.In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Business Partnering Represent Boston Scientific values and perform your role with integrity.Build relationships with corporate regulatory teams to get timely information required for ANZ submissions.Effectively partner with sales, marketing, operations, and other stakeholders to develop sound product and business strategies.Liaise with multiple stakeholders across all levels of the organisation.Take part in continuous improvement projects.KEY COMPETENCIES REQUIRED FOR SUCCESS Integrity and Compliance: Adheres to ethical standards and regulatory requirements.Works effectively with cross-functional teams and external partners.Proactively identifies opportunities for process improvements.Accountability: Takes ownership of tasks and delivers results.Customer Focus: Understands and anticipates the needs of internal and external stakeholders.Adaptability and Resilience: Responds positively to change and remains flexible in a dynamic environment.SKILLS AND QUALIFICATIONS Minimum of 2 years of experience in regulatory affairs within the medical device industry.Bachelor's in science, engineering or a related field is desirable.Experience with Australian Therapeutic Goods Administration (TGA) regulations is preferred.Familiarity with international regulations and requirements is ideal (e.g., FDA, CE Marking).Excellent written and verbal communication skills.Strong analytical thinking and problem-solving skills.Detail-oriented with strong prioritisation and organisational skills.Understanding of medical device regulations and quality management system standards.Ability to work in a team with a collaborative approach.Ability to manage multiple projects and deadlines.Meticulous in reviewing documents and ensuring accuracy.Requisition ID: 594125
#J-18808-Ljbffr
-
Regulatory Affairs Specialist
vor 1 Woche
Melbourne, Österreich Steris Canada Corporation VollzeitRegulatory Affairs and Quality Specialist (Melbourne, VIC)At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.The Difference You Will MakeSTERIS is looking to hire a Regulatory Affairs Specialist in Australia! Reporting to the Regulatory Affairs...
-
Regulatory Affairs Specialist
Vor 7 Tagen
Melbourne, Österreich Tideri Jobbörse VollzeitRegulatory Affairs and Quality Specialist (Melbourne, VIC) At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.The Difference You Will Make STERIS is looking to hire a Regulatory Affairs Specialist in Australia !Reporting to the Regulatory...
-
Regulatory Affairs Specialist
vor 1 Monat
Melbourne, Österreich Steris Canada Corporation VollzeitJob Title: Regulatory Affairs Specialist (Melbourne, VIC) At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.The Difference You Will MakeSTERIS is looking to hire a Regulatory Affairs Specialist in Australia! Reporting to the Regulatory Affairs...
-
Regulatory Affairs Specialist
vor 3 Wochen
Melbourne, Österreich Boston Scientific Gruppe VollzeitABOUT THE ROLE We are seeking an enthusiastic and skilled regulatory specialist to join our Australia and New Zealand (ANZ) Regulatory Affairs team.This role offers a great opportunity with a global medical device leader to further develop your regulatory skills across a broad range of therapies and technologies.The successful candidate will be responsible...
-
Regulatory Affairs Associate
Vor 5 Tagen
Melbourne, Österreich i-Pharm Consulting VollzeitCandidates outside of Melbourne are encouraged to apply, on a fully remote basis! Step into a pivotal role as a Regulatory Affairs Associate with a leading CRO dedicated to driving global health advancements! Join a dynamic team where innovation and precision meet, focusing on Clinical Trials, Regulatory Affairs, and Safety & Biometrics. In this role, you'll...
-
Regulatory Affairs Specialist
vor 2 Monaten
Melbourne, Österreich Steris Ims VollzeitAt STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe. The Difference You Will Make STERIS is looking to hire a Regulatory Affairs Specialist in Australia!Reporting to the Regulatory Affairs and Quality Manager, you will be supporting the...
-
Regulatory Affairs Specialist
vor 4 Wochen
Melbourne, Österreich Beaulieu International Group VollzeitRegulatory Affairs SpecialistDivision: CorporateLocation: Kruisem, BEDate: 24 Oct 2024A new challenge? On top of the regulatory trends?A heart for sustainable products?So do we!Let's grow together. Main responsibilities and key tasks As a member of the global regulatory team, you will:Keep up to date on national, regional (EU, North-America, Australia)...
-
Regulatory Affairs And Quality Specialist
vor 1 Monat
Melbourne, Österreich Steris Canada Corporation VollzeitJob Title: Regulatory Affairs and Quality Specialist (Melbourne, VIC) Job Category: Regulatory Affairs Melbourne, VIC, AU, 3202 Description: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.The Difference You Will MakeSTERIS is looking to...
-
Regulatory Affairs And Quality Specialist
vor 1 Monat
Melbourne, Österreich Tideri Jobbörse VollzeitJob Title: Regulatory Affairs and Quality Specialist (Melbourne, VIC) Job Category: Regulatory Affairs Melbourne, VIC, AU, 3202 Description: At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.The Difference You Will Make STERIS is looking to...
-
Regulatory Affairs Manager
vor 1 Monat
Melbourne, Österreich Novartis Farmacéutica VollzeitInternal Role Title: Regulatory Affairs ManagerLocation: Sydney, Australia #LI-HybridAbout the RoleAs Regulatory Affairs Manager, you will manage, plan, and coordinate submissions to health authorities in Australia and New Zealand.Reporting to the Head of Regulatory Affairs, you will develop strategies to deliver optimal regulatory outcomes, ensuring...
-
Head Of Regulatory Affairs And Pharmacovigilance
vor 1 Monat
Melbourne, Österreich Healthcare Professionals Group VollzeitHealthcare Professionals Group has partnered with this fast-growing biopharmaceutical company in their search for a Regional Head of Regulatory Affairs & Pharmacovigilance.Benefits Newly created role with ANZ and Regional ScopeInnovative pipeline of specialty therapeuticsAttractive salary and benefits package on offerAbout the company Recognised as an...
-
Junior Regulatory Affairs Associate
vor 1 Woche
Melbourne, Österreich Dbg Health VollzeitThis is a great opportunity to get your foot in the door with a growing organisation.14th November, 2024Junior Regulatory Affairs AssociateDBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne. With a team of over 800 dedicated professionals, we are committed to delivering affordable and innovative solutions that...
-
Junior Regulatory Affairs Associate
vor 1 Woche
Melbourne, Österreich Dbg Health VollzeitThis is a great opportunity to get your foot in the door with a growing organisation.14th November, 2024Junior Regulatory Affairs AssociateDBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne.With a team of over 800 dedicated professionals, we are committed to delivering affordable and innovative solutions that...
-
Junior Regulatory Affairs Associate
vor 1 Woche
Melbourne, Österreich Tideri Jobbörse VollzeitThis is a great opportunity to get your foot in the door with a growing organisation.14th November, 2024 Junior Regulatory Affairs Associate DBG Health is a leading independent health, wellness, and beauty company headquartered in Melbourne.With a team of over 800 dedicated professionals, we are committed to delivering affordable and innovative solutions...
-
Regulatory Rules, Obligations
vor 1 Monat
Melbourne, Österreich Tideri Jobbörse VollzeitAbout Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889.Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...
-
Melbourne, Österreich Tideri Jobbörse VollzeitSenior Analyst – Compliance and Regulatory Affairs Crown Resorts is a great place to visit and it's an even better place to work, a place where you can play your part in creating joyful experiences for our guests and our people.We value passion, creativity, and an appetite for change - for the better.Here, you'll be part of the team, empowered to explore...
-
Melbourne, Österreich Tideri Jobbörse VollzeitSenior Analyst – Compliance and Regulatory Affairs Crown Resorts is a great place to visit and it's an even better place to work, a place where you can play your part in creating joyful experiences for our guests and our people.We value passion, creativity, and an appetite for change - for the better.Here, you'll be part of the team, empowered to explore...
-
Melbourne, Österreich Tideri Jobbörse VollzeitSenior Manager, Compliance and Regulatory Affairs Crown Resorts is a great place to visit and it's an even better place to work, a place where you can play your part in creating joyful experiences for our guests and our people.We value passion, creativity, and an appetite for change- for the better.Here, you'll be part of the team, empowered to explore more,...
-
Regulatory Rules, Obligations
vor 2 Wochen
Melbourne, Österreich Northern Trust Corporation VollzeitAbout Northern Trust:Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889.Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...
-
Regulatory Rules, Obligations
vor 1 Monat
Melbourne, Österreich Northern Trust Corporation VollzeitAbout Northern Trust: Northern Trust, a Fortune 500 company, is a globally recognized, award-winning financial institution that has been in continuous operation since 1889.Northern Trust is proud to provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by remaining true to our enduring...
