Senior QA/RA Specialist

• Role of Management Representative (ISO 13485)
• Ensure the processes needed for the Quality Management System are effectively defined, documented, implemented and maintained
• communicate and report on the performance and effectiveness of the QMS and any need for improvement to the senior management team and all other company personnel
• Ensure the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization
• Coordinate and execute to support QMS activities
• Ensure complaint handling / investigations, CAPA, Nonconformities, are processed and resolved in a timely manner
• Suppliers’ management (including evaluation, monitoring, quality agreements)
• Design and Development activities
• Change control
• Internal / external / supplier audits
• Responsible for maintaining and improving QMS, quality documents and records
• Support the creation, maintenance and improvement of new / existing technical documentation
• Support EU MDR certification and maintenance activities
• Support / enable product registrations in new markets
• Apply design quality rigor and support towards new / existing products
• Ensure robust supply and manufacturing product quality, and oversee management of any significant product quality issues
• Ensure complaint handling / investigations are processed and resolved in a timely manner
• Collaborate effectively with Resmed Global teams
• Independently define regulatory strategies and timelines for regulatory submissions for the total product lifecycle for medical and non-medical devices
• Serve as Regulatory representative in the Inhealthcare Product Development team
• Manage preparation and maintenance of regulatory submissions and other premarket registrations
• Ensure timely, professional and proactive communications with internal customers, external customers, and local health agencies
• Control and maintain regulatory records
• Work closely with stakeholders on Regulatory process improvements
• Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments
• Serve as Person Responsible for Regulatory Compliance (PRRC) (MDR 2017/745)
• Serve as Vigilance Officer for Regulatory reporting

• Bachelor's degree (technical or software background preferred) from four year college or university
• at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices
• four (4) to five (5) years related experience or equivalent education and experience
• Strong experience or exposure across Quality Systems (ISO 13485) / Design and Development of Medical device software (IEC 62304 environment)/ Supplier quality / Medical Device Regulation (MDR 2017/745)
• Good Knowledge of ISO 13485 standard and Medical Device Regulation (MDR 2017/745)
• Ability to exercise judgment
• Good communication, planning and organizational skills
• Proactive
• able to provide initiative, ownership while working through uncertainty
• Self-starter, with the ability to work with minimal supervision and with a sense of urgency
• Must be detail oriented & highly organized
• Must demonstrate teamwork building skills in & outside department

Ideally, experience in a software company (IEC 62304 environment) to have a strong proficiency and understanding of health software and medical device software

• All employees benefit from a bonus plan
• Working from home flexibility
• Access to a referral bonus
• Access to ResMed's preferred shareholding programme
• Internal career opportunity