Regulatory Affairs Specialist

**Work mode**:Hybrid**Onsite Location(s)**:Mascot, AU**Hiring Manager**: Juan Sebastian Castiblanco
**Recruiter**: Aislinn Roche**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.-
**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

**Continuous Improvement**
- 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

**Collaboration**:

- Works effectively with cross-functional teams and external partners

**Innovation**:

- 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-orientated 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**Job Segment**:Regulatory Affairs, Compliance, Medical Device, Law, Advertising, Legal, Healthcare, Marketing