Regulatory Affairs (RA) Engineer
Ascom / Logistikjobb / Göteborg
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hela Sverige You will be a part of the global Quality & Regulatory team consisting of 17 persons, both men and women with different backgrounds. The team supports the development of healthcare ICT and mobile workflow products, many of which are medical devices, with compliance to electrical, radio, EMC, medical safety and EX standards and regulations.
As our RA Engineer, your main objective will be to contribute to customer satisfaction and sales growth - by ensuring safety and regulatory compliance of products in the countries where Ascom sells and distributes, including EU/EFTA, US, Canada, Australia and others. Your focus will be on electrical, radio, EMC and medical safety (in particular alarm systems).
In this role, you will work closely with the R&D and product management to identify, interpret, define and establish safety and compliance requirements for Ascom products based on applicable regulations and standards. You will also work with other functions to support and educate about product safety and compliance requirements.
You will be responsible for external verification, documentation, registration/certification, monitoring and maintenance of product compliance. As our RA Engineer, you will represent Ascom towards applicable notified bodies, standardization bodies, nationally recognized testing labs (NRTL's) and other regulatory agencies. You will monitor updates to standards, perform analyses of these and initiate actions with product management and R&D to maintain compliance.
Responsibilities
• Identify applicable regulatory requirements and product standards through analysis of intended use, predicate devices, business requirements and region/country regulations.
• Communicate to, and coordinate with development projects to ensure applicable compliance requirements are identified and captured in the planning and design inputs.
• Work with R&D teams to plan, schedule, coordinate and monitor the compliance testing of products throughout the product lifecycle.
• Support R&D with review of product bills of materials to ensure that critical components are identified.
• Obtain quotes and issue purchase orders for testing, certification/registration and other activities as required to maintain product compliance.
• Prepare product label specifications compliant with applicable standards and regulations.
• Work with technical writers to ensure that instructions for use and other product documentation include the required safety and regulatory information.
• Support R&D projects with resolution of issues affecting safety or compliance.
• Review and sign-off regulatory evidence of compliance to ensure fulfillment.
• Perform regulatory release of assigned products for applicable countries in the ERP system.
• Support investigation of nonconformities (NCR, CAPA) with safety and regulatory compliance assessment, mitigation strategies and evidence/records of compliance. When needed, coordinate compliance mitigation activities between the R&D and NRTL's/regulatory agencies.
• Monitor standards and regulations regarding product safety, certification and conformity. Investigate existing and upcoming regulatory requirements and the interpretation thereof, to ensure continued compliance of the Ascom product portfolio.
For this role we estimate that you will have about 15 travel days per year, domestic and international.
Personal Skills
The keywords confident, persistent, diligent and organized describe you well. You enjoy helping others to deliver with quality and understand the role of regulatory affairs in bringing safe and compliant products to the market. You are an effective communicator both verbally and in writing, and possess a demonstrated ability to work with colleagues, partners and customers on different levels in the organization.
Qualifications
• Bachelor or Master degree, or equivalent, in Engineering or corresponding academic merits
• Minimum five years' relevant working experience within healthcare, ICT or other technology industries, whereof three years' experience of regulatory affairs or R&D;
o Familiarity with EU electrical and ICT safety regulations (e.g. LVD, EMC, RED) and standards is required.
o Knowledge of radio and EMC standards, as well as regulations and standards in US and other non-EU countries, is a strong plus.
o Knowledge of medical device standards for electrical equipment and software (e.g. IEC 60601) is a strong plus.
o Knowledge and experience of development of medical devices, software and/or communications technology (ICT) is a plus.
• Knowledge and experience of delivering presentations and training to professional audiences.
• Excellent command of the English language both verbally and in writing.
• Good knowledge of Microsoft Office.
Working at Ascom
We offer an open and international environment where personal initiative is both expected and appreciated. Our culture is reflected by the Ascom Way and its six principles: Customer Focus, Accountability & Commitment, Growth, Innovation, Leadership, We are Ascom. Key aspects are to create customer value in everything we do, take calculated risks, be curious and creative, and be passionate and inspire. Ascom is a company where you will be able to engage with all parts of the value stream, from development to sales, manufacturing, supply chain and service delivery. If you are motivated by making a real difference in your work, you are probably one of us.
Contact and Application
Are you interested in the job? The selection process is ongoing, so please submit your application as soon as possible.
If you have any questions about the job, please contact Ivan Liljegren, Director Quality & Regulatory, phone +46-700-019270, e-mail
ivan.liljegren@ascom.com or Klara Franson, HR Recruitment Specialist, phone +46-31-559307,
klara.franson@ascom.com .
Varaktighet, arbetstid
Dagtid, Heltid Tillsvidareanställning
Publiceringsdatum2018-10-16ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2018-11-15
Klicka på denna länk för att göra din ansökanKontaktKlara Franson
klara.franson@ascom.comFöretagAscom
AdressAscom
Grimbodalen 2
41749 Göteborg
KontorsadressGrimbodalen 2
Jobbnummer 4404837
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