Senior Regulatory Affairs Specialist – MedTech & Pharma

Starpharma Pty Ltd; Melbourne; Presencial; AUD 120.000 - 180.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive remuneration with cash &?/

Health & wellbeing program

Professional development opportunities

Descripción de la vacante

Starpharma is an innovative Australian biotechnology company in inner Melbourne seeking a Regulatory Affairs professional to support regulatory activities across discovery, development and commercialization of pharmaceutical and medical device products.

You will develop regulatory strategies, prepare submissions, maintain registrations, and guide cross‑functional teams to ensure compliance with global regulatory requirements.

Formación

• Minimum 5 years’ experience in regulatory affairs for medical devices or pharmaceuticals.
• Knowledge of applicable regulatory requirements (ISO 13485, EU MDR, FDA) for development, registration and commercialization.
• Excellent analytical and attention to detail.
• Strong teamwork, collaboration and communication skills.
• Organisational skills with ability to maintain detailed records.
• Willingness to update knowledge and stay current with regulatory changes.

Responsabilidades

• Develop and implement regulatory strategies to support Starpharma's R&D and commercial programs.
• Lead and manage regulatory projects, timelines and cross‑functional coordination.
• Identify and engage regulatory consultants or agents when required.
• Prepare regulatory submissions for devices/drugs to meet timelines and quality standards.
• Maintain registrations and monitor reporting, variations and renewals.
• Support regulatory audits and ensure compliance across activities.

Conocimientos

Regulatory affairs

Cross‑functional work

Regulatory strategy

Project management

Educación

BSc in Biological Sciences

Descripción del empleo

Starpharma is an innovative Australian biotechnology company in inner Melbourne seeking a Regulatory Affairs professional to support regulatory activities across discovery, development and commercialization of pharmaceutical and medical device products.

You will develop regulatory strategies, prepare submissions, maintain registrations, and guide cross‑functional teams to ensure compliance with global regulatory requirements.