Global Regulatory Compliance Associate

5 days ago

City of Parramatta Council, Australia Bayer AG Full time

Responsibilities:

The Senior Regulatory Affairs Associate will be responsible for developing and implementing global regulatory life cycle strategies for radiology medical devices. This includes preparing and submitting complete and compliant submissions and technical documents, driving the review process, leading follow-up meetings, and communicating regulatory strategies and requirements to internal peers and stakeholders.

Additional responsibilities include identifying and mitigating device regulatory risks, upholding change management processes, participating in regular Regulatory Affairs teams global project team meetings, and engaging and collaborating with cross-functional partners.

  • Develop and implement global regulatory life cycle strategies for radiology medical devices.
  • Prepare, write and submit complete, well-structured and detailed submissions and technical documents, ensuring accuracy and compliance.
  • Drive the review process, checking for accuracy, technical consistency and compliance.
  • Lead and conduct follow-up meetings and teleconferences with health authorities.
  • Communicate regulatory strategies and requirements to internal peers and stakeholders.
  • Identify and mitigate device regulatory risks, executing mitigation plans.
  • Uphold change management processes through timely and accurate revisions to technical documentation.
  • Participate in regular Regulatory Affairs teams global project team meetings.
  • Engage and collaborate with cross-functional partners including Regulatory Affairs, R&D, Engineering, Product Supply, QA engineering and Marketing.

Requirements:

  • Minimum of a Bachelor's degree in a relevant field.
  • Substantial experience in Regulatory Affairs, with proven experience managing end-to-end submission processes.
  • Proven successful experience in medical devices or health-related regulatory submissions is essential.
  • Familiarity and hands-on experience working with digital medical device regulations is highly desirable.
  • Knowledge of FDA and EU medical device regulations.
  • Ability to articulate and solve regulatory device issues with little guidance.
  • Excellent written communication and relationship-building skills.

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