Senior QA​/RA Specialist

We are looking for our future Senior QA/RA Specialist to join our Quality Assurance team at Inhealthcare. Let's talk about the role:

The primary role of 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 in every country.

• Role of Management Representative (ISO 13485) to
  • 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, including
  • 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, including Quality Management System compliance, Quality related capability and training and associated support of Audits and Technical Documentation assessments
  • Support / enable product registrations in new markets, in partnership with Regulatory Affairs, Product Development, Operations, Marketing and Commercial teams
  • 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, by driving regulatory strategy, timelines and deliverables
• Manage preparation (developing submission content, management of document legalization/apostille, and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan
• Ensure timely, professional and proactive communications with: (1) internal customers to ensure transparency of the regulatory strategic plans, updates/changes and impact to projected submission approval time frames; (2) external customers to ensure applications are submitted to local health authorities consistent with regulatory strategic plan; and (3) with local health agencies to ensure adequate and appropriate information is provided as well as driving submissions to approval as effectively as possible
• Control and maintain regulatory records, including, but not limited to: submission documentation, tracking of part number approval per country, establishment registrations, etc
• Work closely with stakeholders on Regulatory process improvements to drive efficiency within the Inhealthcare organizations
• Reviews technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry. Evaluates new and changing regulations and its impact to the product, strategic approach, quality system and regulatory submissions for that region
• Collaborate effectively with Resmed Regional and/or Global…