Regulatory Affairs Specialist
vor 4 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 licenses, and maintain compliance to ANZ regulations.
This is a key role in the organization 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 ApplicationDetermine 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 PartneringRepresent 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 organization.Take part in continuous improvement projects.KEY COMPETENCIES REQUIRED FOR SUCCESS Integrity and ComplianceAdheres to ethical standards and regulatory requirements.Works effectively with cross-functional teams and external partners.Proactively identifies opportunities for process improvements.AccountabilityTakes ownership of tasks and delivers results.Customer FocusUnderstands and anticipates the needs of internal and external stakeholders.Adaptability and ResilienceResponds 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 prioritization and organizational 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
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