Senior Regulatory Affairs Associate

at  Bayer

ABOUT US:

Imaxeon Radiology ANZ is a subsidiary of Bayer. We offer a complete solution to optimise efficiency in CT, MRI, Angiography and Nuclear Medicine for today and tomorrow’s imaging environment.
We are patient and customer focused with specialist modality support and industry leading service coverage and we have partnerships with public and private health sector providers within ANZ.

KEY RESPONSIBILITIES:

• Develop and implement global regulatory life cycle strategies.
• 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 authorise.
• Communicate regulatory strategies and requirements to internal peers and stakeholders.
• Identify and mitigate device regulatory risks, executing mitigation plans
• Uphold change management processes through the 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 Reg Affairs, R&D, Engineering, Product Supply, QA engineering and Marketing

To be successful in the role:

• You will hold a 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. Your hands-on experience is crucial to our mission to improve patient outcomes.
• 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 will little guidance
• Excellent written communication and relationship building skills. Your ability to articulate complex information will ensure our compliance