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.  

The main role of this function is to support/maintain an acquired company on all QMS and Regulatory aspects.

Let’s talk about Quality responsibilities:  

• 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​

​Let’s talk about Regulatory responsibilities:  

• 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 timeframes; (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 Regulatory Affairs teams 
• Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including EU MDR, UK MDR, UK NHS, and policies applying to medical devices
• Serve as Person Responsible for Regulatory Compliance (PRRC) (MDR 2017/745) for Inhealthcare for the following aspects:
• the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
• the post-market surveillance obligations are complied with in accordance with Article 10(10);
• the reporting obligations referred to in Articles 87 to 91 are fulfilled;
• in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
• Serve as Vigilance Officer for Regulatory reporting

Let's talk about qualifications and exeperience:

Required

• Bachelor's degree (technical or software background preferred) from four year college or university and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices, in addition to 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 Regualtion (MDR 2017/745)

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

Let’s talk about skills  

Mandatory :

Good Knowledge of ISO 13485 standard and Medical Device Regulation (MDR 2017/745)

Additional information :

• At ResMed, all employees benefit from a bonus plan, the percentage of which depends on your position within the organisation 

• Working from home flexibility

• You also have access to a referral bonus and to ResMed's preferred shareholding programme 

• Internal career opportunity - joining an international fast-pace and massively growing company 

OK, so what's next?

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. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!

#LI-EU

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. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now!