12 дней назад
Regulatory Affairs Engineer (Medical Devices)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Regulatory Affairs Engineer (Medical Devices): Operating and improving post-market surveillance across Neko Health’s medical device portfolio with an accent on PMS procedures, periodic reporting, and regulatory documentation. Focus on applying EU MDR and MDCG requirements across multiple risk classes, streamlining repeatable workflows, and coordinating post-market activities with regulatory, quality, clinical, and engineering teams.
Location: Stockholm, Sweden; hybrid
Company
develops proprietary non-invasive medical technology and combines it with direct clinical care to provide data-driven preventative health insights.
What you will do
- Run and maintain post-market surveillance across the full medical device portfolio.
- Implement, maintain, and continuously improve the post-market surveillance standard operating procedure.
- Produce periodic post-market trend reports and conduct post-market literature searches using repeatable methods.
- Prepare post-market sections of technical documentation and periodic reports for Notified Bodies.
- Support regulatory owners with post-market questions across multiple device programmes and risk classes.
- Contribute to regulatory activities throughout the medical device lifecycle and streamline repetitive workflows.
Requirements
- At least three years of experience in regulatory affairs or quality for medical devices, including substantial post-market experience.
- Knowledge of medical device post-market guidance, EU Regulation 2017/745, applicable MDCG guidance, ISO 13485, and ISO 14971.
- Experience with devices that have been available on the market for several years and with periodic reporting for a Notified Body.
- BSc or MSc in engineering, medicine, pharmacy, law, or another relevant scientific discipline, or equivalent professional experience.
- Excellent analytical and writing skills, with the ability to produce audit-ready regulatory documentation.
- Fluent English, both oral and written, is required.
Nice to have
- Experience automating or streamlining regulatory workflows, including light scripting.
- Experience with Visual Studio Code and Azure DevOps.
- Experience using AI tools such as Claude for research, drafting, and operational efficiency.
Culture & Benefits
- Cross-programme scope across the complete device portfolio.
- Autonomy to determine how the work is carried out, with guidance from the RA Engineering Lead.
- Close collaboration with engineering, clinical, quality, and product teams.
- Small, experienced regulatory team with visible ownership and impact.
- Competitive salary and benefits package.
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