Regulatory Affairs Assistant

2 weeks ago

Saint Leonards, Victoria, Australia Stryker Full time

Regulatory Affairs Associate
If you are passionate about medical devices and regulatory affairs, then Stryker wants to talk to you. We are looking for an Associate to join our high-performing regulatory team.

Responsibilities

  • Review and determine the impact of change notifications for existing devices, including management of registration updates and stakeholder communication.
  • Provide strategic regulatory advice and transfer management for smooth incorporation of product acquisitions.
  • Work closely with key stakeholders to process regulatory actions in accordance with the Therapeutic Goods Administration (TGA), Medsafe and Corporate requirements.
  • Operate with a significant degree of efficiency and independence.
  • Management of annual reports and renewal of licenses to ensure compliance with local regulatory requirements.
  • Maintain corporate compliance by supplying information as required by the Therapeutic Goods Administration (TGA) and Medsafe.
  • Develop new regulatory processes and continuous process improvements.

Skills & Requirements:

  • Tertiary education in a technical discipline (e.g. Science, Engineering, Biomedical or related).
  • Proven experience in Regulatory Affairs with demonstrated success in the analysis and interpretation of regulatory documentation and technical writing.
  • Knowledge of Australian regulatory environments for medical devices (international regulatory knowledge desirable e.g., FDA and EU MDR)
  • Strong negotiation and communication skills to effectively build relationships with key stakeholders, industry bodies and regulatory authorities.
  • Minimum 2 years experience in a similar Regulatory Affairs role.
  • Relevant degree in science or biomedical engineering.

Culture & Benefits:

  • Grow and develop your career with a company that prides itself on personal and professional development.
  • Free parking
  • Free onsite gym
  • Hybrid WFH/office
  • Strong product pipeline

About Stryker:


Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better.


The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes.

Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

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