Quality & Regulatory Affairs Specialist (QA/RA Specialist)

Job Title: Quality & Regulatory Affairs Specialist (QA/RA Specialist)

Location: Remote (European time zones strongly preferred)

Role Description:
Join a fast-growing MedTech startup on a mission to make medical device compliance faster and easier. As a Quality & Regulatory Affairs Specialist, you’ll work hands-on to prepare regulatory submissions, create quality and technical documentation, support clients, and contribute to the development of innovative AI-powered compliance tools.

Sector: Medical Devices, MedTech, AI-driven Regulatory Solutions

Must-Have Skills and Experience:

• Bachelor’s degree in Engineering, Life Sciences, or related field
• 2–4 years’ experience in regulatory or clinical affairs within medical devices
• Hands-on experience preparing technical documentation for EU regulatory submissions
• Solid knowledge of EU MDR (2017/745) and medical device standards (ISO 13485, ISO 14971, IEC 62304)
• Strong client-facing and communication skills
• Ability to work in a fast-paced, dynamic environment (startup experience preferred)
• Collaborate with cross-functional teams including engineering and product development
• Monitor global regulatory changes and adapt processes accordingly

Desirable Skills and Experience:

• Familiarity with US FDA regulations, 510(k), PMA, De Novo, and Q-Submissions
• Experience with Software as a Medical Device (SaMD) and hardware devices
• Knowledge of broader quality systems (CAPA, post-market surveillance)
• Experience with AI tools or prompt engineering with LLMs
• Familiarity with Notified Body conformity assessments and audits

What We Offer:

• Fully remote work with flexible hours
• Competitive salary and equity opportunities
• Opportunity to work at the forefront of MedTech and AI compliance innovation

How to Apply:

Apply directly on LinkedIn. Interviews are moving fast and can be scheduled within a week, so early applications are strongly encouraged. Contact a.brenner@panda-int.com for more info.