Quality Assurance And Regulatory Affairs Manager

Quality Assurance and Regulatory Affairs Manager

Resonance Health Ltd is an ASX listed Medical Technology and Services Company. We provide radiology-image analysis services for clients globally, using regulatory approved software (software as medical devices). One of our products, FerriScan, has been available for over fifteen years and is globally recognised as the gold standard in the measurement of liver iron overload. 

Resonance Health provides services to pharmaceutical and therapeutic companies for their clinical trials, in addition to servicing the international medical community for image data analysis for the diagnosis and management of patients. We are committed to delivering high quality services to the international medical community and are seeking like-minded people to join our team.

About the Role: 

Our Quality Assurance and Regulatory Department ensures that we take a risk-based approach to all we do, whilst ensuring that we understand and meet the quality and Regulatory requirements of the global markets we operate within.

This role is responsible for all aspects of the quality and Regulatory compliance requirements for the organisation. Directing a team of four, this role is focused on implementing and driving a continuous improvement culture to maintain the effectiveness of the Quality Management System.  

We have recently constructed a laboratory and commenced providing clinical trial management services to the market.  Therefore this role will be focused on establishing a quality framework within the laboratory testing area, whilst providing quality oversight on clinical trial management and CRO activities, together with quality compliance in our medical device product design and development area.   

What you will be responsible for:

Duties & responsibilities:

• Create and upkeep of documentation to ensure compliance to ISO13485 and ISO17025, ICH-GCP, GCLP, GMP.
• Ensure the Resonance Health meets applicable regulatory & statutory requirements in all areas (Australia, USA, Europe, United Kingdom)
• Management external stakeholders and ensure clear & effective communication with regulatory authorities. 
• Documentation control & management, change control processes & tracking, vendor qualification & management, and deviation & CAPA management.
• Assessment, co-ordination, preparation & submission of regulatory & reimbursement applications
• Maintain regulatory technical file documentation.
• Participation in review & approval of marketing material
• Ensuring maintenance of the post marketing surveillance systems including adverse event reporting & trend analysis
• Provide regulatory support on additional projects as required.
• Assist with training and professional development of staff and peers.

Experience & attributes:

• Minimum of 5 years' experience in the Medical Device Industry or Laboratory testing, 3 of which have been in Quality (assurance, control, or systems) or Regulatory Affairs.
• Bachelor’s degree (or higher) in relevant field.
• Significant experience in QMS processes and management.
• Effective coaching, leadership, and motivational skills.
• Familiarity with ICH GCP requirements.
• Excellent written & verbal communication and interpersonal skills.
• Self-motivated approach and ability to thrive in a multidisciplinary environment and excellent time management skills.
• Expertise in both pre & post market regulatory activities.
• Proven analytical, problem solving & troubleshooting skills.
• Well versed in building & maintaining relationships with both internal & external stakeholders.

What we offer you: 

• A permanent position in a growing company with an exciting vision. 
• A friendly and happy team environment, working with talented and smart people.
• Floating Public Holidays, so that you can substitute any Public Holiday for another day of your choice.
• Broad flexible working arrangements to enable you to balance collaboration with your other life commitments.
• Head office overlooking a park in a great location in Burswood Road, Burswood with parking, great public transport, and end of trip facilities.
• Market competitive remuneration. 
• We promote internally and focus on the development of our employee.

Recruitment for this role opens on 12th March and closes on 9th April