Senior QA/RA Specialist

We are looking for our future Senior QA/RA Specialist to join our Quality Assurance team at Inhealthcare. 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 in every country.
• Supporting/maintaining 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 complaint handling/investigations, CAPA, Nonconformities.
• 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.
• 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.
• Ensure timely, professional and proactive communications with internal and external customers.
• Control and maintain regulatory records, including 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.
• Review technical publications, articles, and abstracts to stay abreast of regulatory and technical developments in the industry.
• Evaluate 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.
• Demonstrate continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics.
• Serve as Person Responsible for Regulatory Compliance (PRRC) for Inhealthcare.
• Serve as Vigilance Officer for Regulatory reporting.

Let’s talk about qualifications and experience:

• 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 Regulation (MDR 2017/745).
• Preferred experience in a software company (IEC62304 environment) to have a strong proficiency and understanding of health software and medical device software.

Let’s talk about 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, 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.