At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Senior Regulatory Affairs Associate 

 

Radiology medical devicesGlobal regulatory remit Office located in Rydalmere

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ‘Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us.

 

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.
 

Do something that moves you:

As a Senior Regulatory Affairs Associate, you will develop, submit and maintain regulatory activities for a Radiology medical devices through their global lifecycle. You will spearhead regulatory projects by developing, and managing the submission process to secure regulatory approvals (e.g. TGA, FDA, CE Marking, etc.) for international marketing clearance.

Reporting into the VP, Head of Regulatory Medical Devices and Digital based Pittsburgh, this role will collaborate with Bayer teams globally, requiring attendance at early morning or evening meetings on a fortnightly basis. At a local level, you will work closely the Head of APAC Regulatory Affairs from our Rydalmere office in Sydney.

 

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 plansUphold 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

Does this sound like you?
 

To be successful in the role:

You will hold a minimum of a Bachelor’s degree in a relevant fieldSubstantial 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 desirableKnowledge of  FDA and EU medical device regulations.Ability to articulate and solve regulatory device issues will little guidanceExcellent written communication and relationship building skills.  Your ability to articulate complex information will ensure our compliance.

Be You @ Bayer

We are committed to creating a culture where people can be their best, in an environment that values inclusion, diversity and flexibility. At Bayer everyone belongs, regardless of race, colour, ancestry, religion, national origin, citizenship, sexual orientation, age, marital status, disability, gender identity, personality, thinking styles or background. We strongly encourage First Nations people to apply.

If you have a disability or special need that requires accommodation for you to partake in our selection process, please let us know by emailing jobs.anz@bayer.com.
 

Be part of something bigger

At Bayer we support your career. Ready to join our team? Click Apply with an up to date resume before the closing date.

 

 

 

 

Location:

Australia : New South Wales : Rydalmere  

 

Division:

Pharmaceuticals 

 

Reference Code:

837391