Regulatory Affairs Associate at Boston Scientific Corporation Malaysia

Sydney, New South Wales, Australia -

Full Time

Start Date

Immediate

Expiry Date

12 Feb, 26

Salary

0.0

Posted On

14 Nov, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, Communication, Analytical Thinking, Problem-Solving, Teamwork, Collaboration, Attention to Detail, Stakeholder Management, Relationship Building, Organizational Skills, Prioritization, Compliance, Quality Management, Negotiation, Cross-Functional Collaboration, Product Commercialization

Industry

Medical Equipment Manufacturing

Description

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 Collaboration Works effectively with others across the team to achieve goals. Demonstrates proficient communication, and partnership in interactions with others. 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 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 Implements initiatives and objectives that align with individual or team goals.

Responsibilities

Support the development and maintenance of regulatory strategies for product entry and lifecycle management in ANZ. Prepare, review, and submit regulatory dossiers to authorities while ensuring ongoing compliance and supply continuity.