ШвецияRegulatory Affairs Engineer, Manufacturing Lifecycle
3 нед. назад
ШвецияHybrid
regulatory compliancegood manufacturing practicedocumentation
Work on regulatory compliance and design transfer for manufacturing and distribution of medical devices.
О компании
- Neko is redefining what prevention means, from treating illness when it arrives, to sustaining health before it's ever at risk. Our mission: make data-driven, preventative care accessible to more people, before symptoms appear. In a single, non-invasive visit under an hour, proprietary technology and direct clinical care combine to deliver personalised, actionable insights. It's a team that thinks in 10x, not 10%. Every role here plays a part in building a world where prevention is the norm, and where your work genuinely helps people live longer, healthier lives.
Обязанности
- 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.
- 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.
Условия
- A clearly defined area of work, end to end, in a company that builds its own hardware.
- Direct working relationships with production, engineering, and quality, on site rather than at a distance.
- Direct guidance from an experienced RA Engineering Lead, and room to grow into wider ownership.
- A small, experienced regulatory team where your judgement carries weight and your contributions are visible.
- Competitive salary and benefits package.
- This role is based in Stockholm, Sweden, within close proximity to our manufacturing site. Regular on-site presence with the production team is required, although some remote work is permitted. All manufacturing and shipments are carried out from Sweden.
Другое
- 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.
- Neko designs and manufactures its own devices, so the distance between a design decision and a device coming off the line is short and you will see both ends of it. You will work on design transfer while it is being built into a repeatable process, and you will be the person the company relies on for how its devices reach the markets we ship to. Both have a direct, visible effect on what gets delivered.