Senior QA/RA Specialist
ResMed
- Harrogate, England, United Kingdom
- Harrogate, England, United Kingdom
Über
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 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
Ideally, 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 Mandatory : 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
While performing the duties of this job, the employee is regularly required to sit and talk or hear . The employee is occasionally required to stand and walk.
Equivalent combination of experience and/or education may be considered
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!
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Sprachkenntnisse
- English
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