Junior Regulatory Affairs Engineer

Quality & Regulatory
SE Gothenburg

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March 26, 2024

We Are looking for …

A Junior Regulatory Affairs Engineer with an appetite to learn and with a hands-on attitude to support compliance activities, collaborating with both internal and external actors. A future star who will be organizing, documenting, and supporting all aspects of Ascom Mobile devices compliance throughout its lifecycle. In this role you will also be supporting the regulatory team with product safety and compliance. You contribute to Ascom’s success by maintaining regulatory access to key markets.  As this role will work closely together with R&D, a technical background is a necessity. It is essential for effective collaboration and understanding of the complex aspects of research and development process and where they connect with Regulatory Affairs. Having a solid technical foundation provides the necessary toolkit to thrive in this role. This role is based in Gothenburg office.

What you will be doing …

  • Obtain, organize, file and retrieve regulatory evidence of compliance.
  • Stay updated about applicable regulatory and quality requirements; monitor standards and legislation regarding product safety, certification, and conformity, i.e. Radio Directive, EMC, etc.
  • Support product and service development teams to ensure compliance to design controls and design and development processes.
  • Support in maintaining regulatory conformity, certifications and approvals for Ascom Mobile devices developed or supplied by Ascom including regulatory requirements for product approval and certification for intended markets.
  • Maintain relationships with test houses, third party suppliers, partners, auditors, etc. and support in managing tests, audits and regulatory compliance with different external parties.
  • Participate in and support internal and external quality audits in coordination with the Quality System Manager.

Our Ideal candidate has …

  • Bachelor's degree in Engineering, Information Technology, or equivalent education, preferably in electronics, information or mechanical engineering
  • General knowledge of design in electronics and preferably also in mechanics
  • Ability to work both independently and in teams.
  • Good analytical and problem-solving skills.
  • Good interpersonal skills with the ability to create and maintain relationships with test houses, third party suppliers, auditors etc.
  • Good communication skills with the ability to collaborate and communicate with external parties in a formal manner, requiring high degrees of tact, diligence and professionalism.
  • Good computer skills, specifically Microsoft Office and tools used for product creation, quality assurance and compliance
  • Ability to multitask product, project and region / site level priorities.
  • Good knowledge of English language, speaking and writing.

What we offer you …

  • A company you can take pride in
  • Inspiring and collaborative colleagues
  • Abundant opportunities for personal and professional growth
  • The chance to work for a company with cutting-edge technology in the mobility and healthcare industry.

We are …

Ascom is a global solutions provider focused on Healthcare ICT and mobile workflow solutions. Headquartered in Switzerland, our business spans across 18 countries, and has been supporting the healthcare industry for 160 years by providing them with technology to enable them to support their communities.

Our systems are used in over 12,000 hospitals worldwide and handle more than 800 million alerts each year (over 2 million alerts a day!). Our solutions positively impact the lives of everyone who visits 1 of the hospitals or care-homes we work with.

Together we can make a difference in the lives of the people who benefit from our technology.

To learn more about what we do, visit us at: www.ascom.com

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