Senior QA/RA Specialist
Join to apply for the Senior QA/RA Specialist role at Resmed.
We are looking for our future Senior QA/RA Specialist to join our Quality Assurance team at Inhealthcare.
About the role
The primary role of the Quality Assurance function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer’s quality requirements.
Key deliverables include creating and building relationships with medical device regulatory bodies in every country.
The main role of this function is to support/maintain an acquired company on all QMS and Regulatory aspects.
Quality Responsibilities
Act as Management Representative (ISO 13485):
Ensure 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.
Promote awareness of applicable regulatory requirements and quality management system requirements throughout the organization.
Coordinate and execute QMS activities:
Complaint handling / investigations, CAPA, nonconformities processed and resolved in a timely manner.
Suppliers’ management (evaluation, monitoring, quality agreements).
Design and Development activities.
Change control.
Internal / external / supplier audits.
Maintain and improve 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 to new / existing products.
Ensure robust supply and manufacturing product quality, and oversee management of any significant product quality issues.
Collaborate effectively with Resmed Global teams.
Regulatory Responsibilities
Define regulatory strategies and timelines for regulatory submissions throughout the product lifecycle.
Serve as Regulatory representative in the Inhealthcare Product Development team.
Manage preparation and maintenance of regulatory submissions and premarket registrations.
Communicate proactively with internal and external customers and local health authorities.
Maintain regulatory records (submission documentation, tracking of approvals, establishment registrations, etc.).
Work closely with stakeholders on regulatory process improvements.
Review technical publications to stay abreast of regulatory and technical developments.
Collaborate with Resmed Regional and/or Global Regulatory Affairs teams.
Serve as Person Responsible for Regulatory Compliance (PRRC) for Inhealthcare (MDR 2017/745) and as Vigilance Officer.
Qualifications and Experience
Required:
Bachelor’s degree (technical or software background preferred) from a four‑year college or university.
At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices, plus four to five years of 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), Supplier quality, and Medical Device Regulation (MDR 2017/745).
Preferred:
Experience in a software company (IEC 62304 environment) with strong proficiency and understanding of health software and medical device software.
Skills
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 and ownership while working through uncertainty.
Self‑starter with minimal supervision and a sense of urgency.
Detail oriented & highly organized.
Teamwork building skills within and outside the department.
Physically, the employee is regularly required to sit, talk or hear, occasionally required to stand and walk.
Equivalent combination of experience and/or education may be considered.
Additional Information
All employees benefit from a bonus plan, the percentage of which depends on the employee’s position within the organisation.
Working from home flexibility.
Referral bonus and ResMed’s preferred shareholding programme.
Internal career opportunity – joining an international fast‑pace and massively growing company.
Next Steps
Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thriving on the innovative ideas this generates. If this sounds like the workplace for you, apply now!
Location: Dublin, County Dublin, Ireland.
Seniority level: Mid‑Senior level.
Employment type: Full‑time.
Job function: Quality Assurance.
Industries: Software Development, IT Services and Consulting, and Medical Equipment Manufacturing.
#J-18808-Ljbffr