Regulatory Affairs Associate

Hiring Manager: Juan Sebastian Castiblanco

Recruiter: Aislinn Roche

# ABOUT THE ROLE

We are seeking an enthusiastic and collaborative Regulatory Affairs Associate to join our Australia and New Zealand Regulatory Affairs team. This is an opportunity for an early-career professional to develop regulatory expertise across a broad range of therapies and innovative medical technologies with a global medical technology leader.

Working closely with the ANZ Regulatory Affairs Manager and broader Regulatory Affairs team, you will support the preparation and submission of regulatory applications to Australia's Therapeutic Goods Administration (TGA) and New Zealand's Medsafe, help maintain existing product registrations and support ongoing compliance with applicable regulatory requirements.

This role is based in Mascot, Sydney and will report to the Regulatory Affairs Manager.

# KEY RESPONSIBILITIES

Regulatory Knowledge and Application

• Support preparation and submission of regulatory applications to the TGA and Medsafe.
• Maintain existing product registrations throughout their lifecycle.
• Support regulatory strategies for product introductions and changes.
• Review promotional materials for compliance with applicable regulations and industry codes.
• Maintain accurate regulatory documentation and 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

Digital &Continuous Improvement

• Explore and utilise AI, automation and digital technologies to support process improvements and enhance productivity.
• Contribute to a culture of continuous improvement by challenging existing processes, recommending innovative solutions, and supporting the implementation of sustainable improvements across the business.

Cross Functional Collaboration

• Liaise with multiple stakeholders across all levels of the organisation
• Build collaborative relationships with commercial, quality, operations and global regulatory teams.
• Represent Boston Scientific values and perform your role with integrity.

# 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.

Relationship Building

• Establishes and maintains strong relationships internally and externally. Contributes to a culture of respect, diversity, and inclusion.
• Earns the respect and trust of others through effective interpersonal skills, integrity and authenticity.

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

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.

Courage

• 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, pharmacy, engineering or a related field is desirable
• Previous experience in regulatory affairs or quality within the pharma/medical device industry is desired, but not essential.
• Strong analytical and problem-solving skills, with the ability to think critically and approach challenges in a structured way.
• Excellent written and verbal communication skills, with the confidence to work across a variety of stakeholders.
• A curious mindset and a genuine enthusiasm for learning, development, and continuous improvement.
• A keen eye for detail and a commitment to producing high-quality work.
• A collaborative approach and the ability to build positive working relationships across diverse teams.
• Confidence using Microsoft Office applications, with experience using digital collaboration tools viewed favourably.
• An interest in emerging technologies, including Artificial Intelligence (AI), and a desire to champion the use of digital tools to improve processes, drive efficiency, and enhance the way work gets done.

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: 633707