AddressAbout Us
Our client is a high-tech global Medical Device company specializing in designing, manufacturing, and marketing a premium line of equipment. They are currently seeking a Senior Manager - Quality & Regulatory to join their team in Adelaide.
About the role:
- Lead and mentor a team of Quality and Regulatory professionals, fostering a culture of excellence and continuous improvement.
- Build and maintain strong relationships with internal and external stakeholders, ensuring effective communication and collaboration on all aspects of QMS and Regulatory Affairs.
- Ensure full compliance with industry standards
- Oversee the performance of the Ellex Medical Quality Management System (QMS), providing management with insights and recommendations for business capability enhancement.
- Act as the "Person Responsible for Regulatory Compliance" (PRRC), ensuring adherence to regulatory requirements.
- Stay informed about industry regulatory changes and their potential impacts on the company, ensuring ongoing compliance and certification of company products.
Skills and Experience:
- Bachelor's degree in a relevant field such as Quality Management, Regulatory Affairs, Biomedical Engineering, or related discipline.
- Minimum of 8-10 years of experience in Quality and Regulatory roles within the Medical Device industry.
- In-depth knowledge of ISO 13485, FDA QSR, MDD, PMDA, and CMDR regulations.
- Proven experience in leading and managing quality and regulatory teams.
- Strong understanding of Quality Management Systems (QMS) and Regulatory Affairs.
- Excellent communication and interpersonal skills, with the ability to build and maintain strong stakeholder relationships.
- Demonstrated ability to drive continuous improvement and ensure compliance in a fast-paced environment.
- Certification in quality management (e.g., ASQ CQA, CQE) or regulatory affairs (e.g., RAPS RAC) is highly desirable
HOW TO APPLY
You must have the right to live and work in Australia to apply for this role. Click "APPLY NOW" to register for this role or contact San Wong at ********@persolkelly.com.au and quote reference - 210251165 for any enquiries. Please note that due to the high volume of applicants, only shortlisted candidates will be contacted
You will be provided with a supportive environment and infrastructure to allow you to thrive, yet the flexibility to allow you to make your mark in the firm. You will also be rewarded with a competitive salary dependent upon experience and on- going commitment to professional development and advancement. Only applicants shortlisted for an interview will be contacted.
Who are we
At PERSOLKELLY, our passion is - and always has been - putting you first.
We propel our people forward by supporting their careers in fresh ways, backed by our expertise and capability.
We're committed to creating a safe and inclusive environment which values and respects diverse styles, backgrounds, experience and perspectives.
We welcome and encourage women, people of Aboriginal and Torres Strait Islander descent and people from diverse backgrounds to apply.
So it's over to you. If you would like to join our team, please APPLY now.
To learn more about working with PERSOLKELLY, we encourage you to visit our website.
Follow our LinkedIn page at linkedin.com/company/persolkelly for the latest updates and insights.
