Regulatory Affairs Associate

Hiring Manager:
Juan Sebastian Castiblanco

Recruiter:
Aislinn Roche

About The Role
We are seeking an enthusiastic and skilled regulatory Associate 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.

This is a hybrid role is based in Mascot, New South Wales and will report to the Regulatory Affairs Manager.

Key Responsibilities
Regulatory Knowledge and Application

• Support the development and maintain effective regulatory strategies for product entry and lifecycle management in ANZ, identifying potential issues early in the process.
• Prepare, review, and submit regulatory dossiers to authorities, and manage changes to ensure ongoing compliance and supply continuity.
• Stay current with ANZ regulatory requirements and proactively apply updates as needed.
• Liaise with regulatory authorities and negotiate submission details as required.
• Collaborate with cross-functional teams to support product commercialisation and ensure compliance of promotional materials with regulations and the MTAA industry advertising code.
• Maintain accurate and up-to-date regulatory and quality records.
• 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

Cross Functional Collaboration

• 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 commercial, operations, and other stakeholders to develop sound product and business strategies

Continuous Improvement

• Liaise with multiple stakeholders across all levels of the organisation
• Take initiative and support continuous improvement projects.

Key Competencies Required For Success
Collaboration

• Works effectively with others across the team to achieve goals.
• Demonstrates proficient communication, and partnership in interactions with others.

Communication

• Communicates effectively one-on-one and in groups, openly shares knowledge and expertise.
• Listens actively and contributes to the open expression of ideas and opinions.

Customer Focus

• Identifies customer needs and ensures the effective delivery of high-quality solutions, products, and services that meet or exceed customer expectations.
• Consistently strives to provide high quality responses to customers
• Uses stakeholder engagement and customer feedback to identify improvement opportunities
• Takes accountability and follows up on requests from others in a timely manner

Adaptability

• Responds resourcefully, flexibly, and positively when faced with new challenges and demands. Moves forward productively and optimistically under conditions of change or uncertainty.
• Remains flexible when overcoming unplanned obstacles

Planning & Execution

• Implements initiatives and objectives that align with individual or team goals. Carries out initiatives with clear deliverables, milestones, accountabilities and measures of success
• Pursues all assignments and projects until completion, following through on assignments to ensure successful completion

C
ourage

• Confronts problems directly, taking action and being decisive. Take risks to do what is right to achieve success.
• Speaks up and challenges the status quo, champions own ideas and those of others

Your Experience And Skills

• Bachelor's in science, engineering or a related field is desirable
• 1-2 years of experience in regulatory affairs within the pharma/medical device industry is desired.
• Experience with Australian Therapeutic Goods Administration (TGA) regulations is preferred.
• Excellent communication skills, both written and verbal.
• Highly organised with excellent prioritisation skills.
• Meticulous attention to detail in reviewing documentation and ensuring accuracy.
• Strong analytical thinking and problem-solving skills.
• Teamwork and collaboration, ability to work independently and as part of a team.
• Strong stakeholder management and relationship building skills

WHY CHOOSE US?

• Great Place To Work Certified in 2024 & 2025
• Best Workplaces for Women in 2024 & 2025
• Inclusive Employee Resource Groups
• 2 Wellbeing Days per year
• Discounted health insurance
• Ability to purchase additional Annual Leave
• Employee Stock Purchase Plan
• Access to Employee Assistance Program

Requisition ID:
618440