Fréttablaðið - 16.10.2021, Page 51

We kindly ask you to submit the Job application, CV and cover letter in English. The application deadline is October 25th. We are always interested
in talented individuals who share our passion for improving people’s lives. Nox Medical embraces diversity. As an equal opportunities employer, we
believe the foundation of our dynamic and pioneering spirit starts with a fair and inclusive culture. Our company culture focuses on bringing unique
ideas and people together to spark innovation and teamwork. All applications will be replied to and are treated with utmost care and confidentiality.
Quality Specialist
In the position as Quality specialist you will be working in an ISO 13485:2016/MDSAP
certified Quality Management environment where great team spirit, cooperation and
solution-oriented mindset is what we strive for in our projects and daily operations.
Function & Responsibilities
• Responsible for reviewing quality outputs for compliance to national and internal
quality system requirements
• Responsible for reviewing and assessing change control, validation,
and qualification documents
• Contributes to CAPA and NCR System, including reviewing the adequacy of root
cause, corrections, corrective actions, preventative actions and effectiveness
• Participates in cross-functional development projects in a quality assurance role
• Participates and/or conducts internal/supplier audits
• Provides support during audits conducted by Nox Medical’s Notified Body (NB)/
Conformity Assessment Bodies (CAB) and Regulatory Authorities (RA) and
formulating the appropriate response and corrective actions
Qualifications
• B.Sc. / M.Sc. degree in related field or equivalent experience required
• 3+ years experience in quality assurance/quality control in medical device/
pharmaceutical industry
• Qualification/Skill to conduct internal audits
• Exercise judgment within defined procedures and practices to determine
appropriate action
• Strong documentation skills
• Excellent English skills, both verbal and written
Project Manager
In this position as Project Manager (PM) in our Clinical Trials Program you will be
responsible for managing implementations of Nox Medical customer solutions, enabling
successful clinical trials from start to finish together with our strategic business
partners.
Function & Responsibilities
• Application of long-term project management skills to realize a timely solution
delivery while addressing the associated business objectives within the defined
project scope
• Developing project scopes and objectives, involving all relevant internal and
external stakeholders ensuring technical and operational feasibility
• Coordinate internal and external resources for the execution of client-facing
solution projects
• Ensure transparent and regular reporting on project progress and escalation of
risks as needed
• Create and maintain comprehensive project documentation according to internal
and customer requirements
Qualifications
• Bachelor or master’s degree in project management, engineering or equivalent
experience
• 5+ years’ experience in technical, clinical or pharma project management of
customer solution implementations, managing multiple projects simultaneously
• Strong analytical skills to investigate problems and processes with a solution-
oriented, continuous improvement mindset
• Solid technical background, with understanding or hands-on experience in
hardware or software solution implementation
• Excellent English communication skills, both verbal and written
Is this your dream job?
We are seeking talented people to join our team of energetic and passionate people.
Nox Medical is a global leader in sleep diagnostics with a vision centered on telemedicine
and delivering better sleep solutions to help people wake up to a brighter world each day.
Regulatory Affairs Associate
The Regulatory Affairs Associate will participate in cross-functional team projects
relating to design and development of medical devices, market registrations and
implement/improvement projects to ensure regulatory compliance of the manufacturer
and the medical device throughout its life cycle.
Function & Responsibilities
• Assist with preparing/compiling regulatory documents for international product
registration
• Participates in developing, implementing, and maintaining the necessary internal
procedures to ensure the company’s ongoing compliance with national and
international regulations/requirements
• Research applicable national and international standards, and guidance to provide
input to the company’s ongoing compliance
• Provide support during audits conducted by Notified Body/Conformity
Assessment Bodies and Regulatory Authorities
Qualifications
• B.Sc. degree in Biomedicine, Engineering, Biological Science, Chemistry,
Pharmacology, or equivalent experience required
• Good planning/organizational and problem-solving skills
• Exercise judgment within defined procedures and practices to determine
appropriate action
• Experience with medical device regulatory affairs, submissions, compliance
programs and quality systems is an advantage
• Excellent oral and written communication skills
• Excellent English skills, both verbal and written
Associate Project Manager
In this position as Associate Project Manager in our Medical Systems Program you will
be supporting the management of Nox Medical R&D projects enabling successful medical
device delivery from start to finish together with our internal R&D, Regulatory and Product
Management teams among others.
Function & Responsibilities
• Application of project management skills to realize a timely
solution delivery within the defined project scope
• Develop a detailed project plan to track progress
• Manage and track changes in project scope, schedule and costs
• Ensure transparent and regular reporting on project progress
and escalation of risks as needed
• Create and maintain comprehensive project documentation
according to internal requirements
Qualifications
• Master’s degree in project management, engineering
or equivalent experience
• Good analytical skills and high interest in investigating
problems and processes
• High interest in understanding the technical background
of medical hardware and software solutions, their implementation
and project documentation in a regulated environment (ISO13485)
• Interest to work in distributed teams across different countries,
cultures and time zones
• Very good English communication skills, both verbal and written
Please apply via our homepage www.noxmedical.com/jobs