AI Deployment Strategist – MedTech Regulatory Affairs

Meyandy LLC; Berlin; Hybrid; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

REMATIQ in Berlin is seeking an AI Deployment Strategist, MedTech Regulatory Affairs to guide customers through regulatory workflows and AI-powered improvements. The role combines regulatory expertise with hands-on project delivery in a fast-growing setting.

You will work with Regulatory Affairs, R&D, and Quality teams to map processes, design compliant solutions, and produce actionable outputs for customers in the MedTech space.

Qualifikationen

• 5–8 years of relevant experience in MedTech Regulatory Affairs, regulatory strategy, or related consulting.
• Practical understanding of regulatory pathways, submissions, design controls, risk management, audits, and documentation.
• Strong project ownership with ability to align stakeholders and drive cross-functional work.
• Excellent customer-facing communication and ability to translate complex topics.

Aufgaben

• Own and drive customer project workstreams from discovery through delivery.
• Collaborate with Regulatory Affairs, R&D, Quality, and cross-functional teams on regulatory workflows and AI-powered improvements.
• Create workshop materials, workflow maps, gap analyses, and use-case specs with experts.
• Translate customer feedback into structured internal product and engineering input.
• Leverage AI tools to speed up deliverables and improve project outcomes.

Kenntnisse

MedTech Regulatory Affairs

Project ownership

Customer-facing communication

AI-enabled use cases

Workflow design and mapping

Jobbeschreibung

About REMATIQ REMATIQ is changing how MedTech teams develop, document, and launch medical devices by building a highly specialised AI platform for regulated R&D, quality, and regulatory workflows. We work with leading life sciences and MedTech companies to help them move faster while improving quality, traceability, and compliance. We are looking for an AI Deployment Strategist, MedTech Regulatory Affairs to help our customers transform complex regulatory workflows into practical AI-powered solutions. We believe in the value of in-person collaboration and work in a hybrid setup, with the team coming together in our office in the heart of Berlin-Mitte typically four days per week.

What you’ll do

• Own and drive customer project workstreams from discovery through workflow design, implementation support, testing, iteration, and delivery.
• Work directly with Regulatory Affairs, R&D, Quality, and cross-functional customer teams to understand regulatory submissions, regulatory intelligence and compliance workflows, product development processes, documentation, constraints, pain points, and opportunities for AI-powered improvement.
• Bring deep MedTech Regulatory Affairs expertise across areas such as regulatory strategy and intelligence, submissions, compliance, design assurance, audits, and interactions with adjacent R&D and quality processes — and act as a domain sparring partner for internal teams.
• Create and review project deliverables such as customer workshop materials, workflow maps, gap analyses, impact assessments, target process designs, use-case specifications, and AI-generated outputs together with customer subject-matter experts.
• Collect customer learnings and feedback and translate them into structured internal feedback for Product and Engineering.
• Use AI tools actively to speed up your own work, create high-quality outputs faster, and improve how customer projects are delivered.

What we’re looking for

We are looking for someone who combines deep MedTech Regulatory Affairs expertise, strong project ownership, customer-facing communication, and a hands-on execution mindset. You may be a strong fit if you have:

• 5–8 years of relevant experience in MedTech Regulatory Affairs, regulatory strategy, regulatory operations, design assurance, or a related consulting role.
• Practical understanding of how medical devices move through regulated development and regulatory pathways, including areas such as regulatory strategy, submissions, design controls, requirements and risk management, verification & validation, design reviews, audits, and technical documentation — and the ability to translate this expertise into AI-enabled use cases, project deliverables, and structured product feedback.
• Strong project ownership: you can structure ambiguous work, align stakeholders, manage risks, define next steps, and drive cross-functional customer projects from problem understanding to delivery.
• Strong customer-facing communication: you can build trust with Regulatory Affairs, R&D, Quality, and senior stakeholders, ask sharp questions, and explain complex topics clearly.
• Hands-on execution mindset: you are comfortable creating materials, mapping workflows, reviewing outputs, synthesising findings, adapting to changing priorities, and driving work forward yourself.
• Comfort with speed and change: REMATIQ is growing extremely fast, with the organisa…

AI Deployment Strategist – MedTech Regulatory Affairs — Rematiq Gmbh, Berlin.