Senior Compliance Specialist – Wireless

Together we can make a difference

Arjo is a global company with a Swedish heritage, where a thriving international environment is driven by Swedish culture. As a company that puts people at the heart of everything we do, Arjo employees are company partners supporting the mission to improve lives where they can explore challenging and rewarding careers in a wide range of specialties across the Arjo global network.

The Position

Are you interested in electronics, software and wireless communication standards and willing to learn more about medical device regulatory affairs? Do you thrive in a highly international environment and would be interested in working for a leading global medical technology company? Then send in your resume to us for consideration for a Senior Compliance Specialist at Arjo!

Key responsibilities

The Arjo Senior Compliance Specialist Wireless participate in establishing global regulatory strategies/ plans including development of documentation that lead to new product submissions in support of global product marketing approvals. This position ensures that products and services built on electronics, software and wireless technology are compliant with appropriate regulations and guidance along with participating in maintaining a strong working relationship with agencies, notified bodies, and organizations that govern products.

  • You will support new product development teams by assessing regulatory requirements required to achieve rapid market clearances and approvals.
  • Provide effective communication to project teams regarding new regulations, policies and initiatives that could impact products and processes.
  • Assist in implementing manufacturing documentation for new products.
  • Participate on product development teams to develop global regulatory strategy and determine what regulatory submissions are required to market the product globally.
  • Maintain open communications with FDA and other regulatory agencies.
  • Prepare and file required documentation for electronics, software and telecommunications regional agency requirements.
  • Interpret and utilize telecommunication laws and regulations and provide advice regarding global laws and regulations.
  • Ensure that the product design and features meet regional confidentiality data requirements (such as patient identifiable data points).
  • Interpret and utilize pertinent regional cybersecurity requirements.

Ideal candidate

The ideal candidate has a mix of regulatory background from working with medical devices with technical understanding preferably from design of electronics, software development and an insight into short range connectivity and wireless standards.

We believe you have competence and experience exemplified by below areas:

  • Minimum B.A. or B.S. degree with a major in a scientific discipline.
  • Preferably an interest in or regulatory experience in the medical device industry and in QA/RA.
  • Basic understanding in design of electronics and programming of software to the level that you can translate relevant parts of standards and paragraphs into clear engineering requirements.
  • Ability to work well on cross-functional teams with experience supporting product design and development projects.
  • Ability to multi-task and prioritize; superb attention to details and complete tasks.
  • Leadership and organizational skills, must be able to render clear and accurate judgments.
  • Excellent written and verbal communication skills.

To succeed in the position it’s also desired that you have

  • Working knowledge of telecommunications and wireless (i.e. WiFi/BT and cellular communications) device regulations including but not limited to: FCC (US), CE (EU), CRTC (Canada), ETSI.
  • Working knowledge of area specific standards.
  • Knowledge of Type Approval and Operator approval processes
  • Experience of global medical device regulations including Medical Devices Directive (MDD), European Medical Device Regulation (EU MDR), FDA CFR among other region regulations, is an advantage. Further knowledge of WEEE and RoHS directives is a merit.

The role is global and based at Arjo Head Quarters in Malmö, Sweden.

Sounds interesting?

Please, send in your resume via “Sök tjänst”. We do not accept applications via email. If you have any questions related to the role, please contact recruiter Johanna Isberg, johanna.isberg@roirekrytering , 0705-84 33 83. Applications will be evaluated on a continuous basis.

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