Regulatory Affairs Engineer, Manufacturing Lifecycle

We are looking for a regulatory affairs or quality engineer to work on design transfer and on the regulatory compliance of manufacturing and distribution at Neko.

This role sits at the point where a finished design becomes a manufactured device. Day to day you will work on the transfer of products from engineering into production, on the good manufacturing practice requirements that apply once a device is being built, and on the documentation that has to be in place before a device can be released and shipped to the markets where we operate.

The work is hands-on and close to the factory floor: with the production team, in the records created when a device is built, and in the paperwork that has to be right before a shipment leaves. You will report to the RA Engineering Lead, who sets the priorities and supports you on the regulatory judgement calls.

Depending on experience, the position may be hired as either a Regulatory Affairs Engineer or an RA Engineering Lead.

• Help turn the handover from engineering into production into a controlled process that satisfies good manufacturing practice requirements (design transfer).
• Apply and maintain the regulatory requirements for the controls on components entering the manufacturing facility.
• Apply and maintain the regulatory requirements for calibration and maintenance of manufacturing equipment.
• Look after the manufacturing records created when a device is built, and the records required to release it.
• Prepare, and be accountable for, the documentation for shipments to other markets, particularly the US, including customs documentation and accompanying FDA documentation, prepared for each individual shipment.
• Coordinate each shipment with production, ensuring that what Neko declares to the FDA is prepared by regulatory affairs.
• Monitor good manufacturing practice across the devices we build, and raise and follow up on any gaps found.
• Work day-to-day with the production and manufacturing teams on site.
• Contribute as a regulatory affairs engineer to product-related regulatory activities where manufacturing and distribution are involved.

Who will thrive in this role

You are likely to thrive if you:

• Work operationally and enjoy it, with success measured by correct shipment documentation and adherence to good manufacturing practice on every device built.
• Understand regulatory obligations for medical device manufacturing, including incoming component controls, equipment calibration and maintenance, manufacturing records, and device release records.
• Have experience looking at manufacturing from the regulatory or quality side.
• Confident and experienced enough to collaborate with an established production team and advocate for needed changes.
• Prefer being physically present where devices are produced.
• Enjoy formalizing informal practices into documented and repeatable processes.

Background and experience

• Hold a BSc or MSc in engineering, a relevant scientific or technical discipline, or have equivalent professional experience.
• Have three to five years of experience in quality or regulatory affairs for medical devices, with direct exposure to manufacturing. Either background is suitable, but a strong understanding of regulatory requirements for device manufacturing is essential.
• Possess working knowledge of ISO 13485, EU Regulation 2017/745 (MDR), and FDA 21 CFR Part 820, with particular emphasis on production and process control as well as device release requirements.
• Familiar with the documentation required for exporting medical devices, including FDA import requirements and customs documentation.
• Experienced in supporting design transfer or production process validation.
• Fluent in English (oral and written); knowledge of Swedish is a plus.
• Comfortable using AI tools, such as Claude, for research, drafting, and enhancing operational efficiency.
• Experience with Visual Studio Code and Azure DevOps is a plus.