AI Deployment Strategist – MedTech Regulatory Affairs

United States Digital Space LLC; Berlin; Hybrid; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 5-8 years in MedTech Regulatory Affairs or related consulting roles.
• Understanding of regulatory pathways for medical devices and AI-enabled workflows.
• Strong project ownership and cross-functional leadership.
• Fluent English; German is a strong plus for German-speaking work.
• Hands-on with structuring problems, creating materials, and translating domain expertise into actionable outputs.

Aufgaben

• Own and drive customer project workstreams from discovery through workflow design, implementation, testing, and delivery.
• Collaborate with Regulatory Affairs, R&D, Quality, and cross-functional teams to map regulatory processes and AI-enabled improvements.
• Bring MedTech regulatory expertise to design and review AI-driven use cases and deliverables.
• Create materials, workshop content, workflow maps, gap analyses, and AI-generated outputs with SMEs.
• Capture customer feedback and translate it into internal product and engineering inputs.

Kenntnisse

Regulatory Affairs

Regulatory Strategy

Submissions

Design Controls

Audits

R&D collaboration

AI tooling

Project ownership

Jobbeschreibung

About REMATIQREMATIQ 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

As an AI Deployment Strategist, MedTech Regulatory Affairs at the company, you will work closely with customers, Delivery, Product, and Engineering to drive customer projects, understand how MedTech regulatory teams work today, and help translate these workflows into high-impact AI use cases.

This is not an academic advisory role. You will be hands-on in customer projects, helping structure problems, drive workstreams, create materials, review outputs, and turn domain expertise into practical solutions.

You will:

• 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: the company is growing extremely fast, with the organisation doubling every 9-12 months. You are comfortable operating in a high-speed, high-agency environment with rapidly changing scope and responsibilities.
• AI savviness: you actively use AI tools to improve your own work, move faster, create better deliverables, and explore new ways of working.
• Fluency in English; German is a strong plus for German-speaking customer work.

Why join the company

Rare timing: Join the company at a pivotal stage as we move from Seed toward Series A and prepare to significantly grow the team.

• Real ownership: Own high-impact customer projects and see your work translate directly into outcomes for leading MedTech and life sciences companies.
• Direct exposure: Work closely with founders, customers, product teams, and technical experts while building a network across the global MedTech and life sciences industry.
• Purposeful work: Be part of a mission-driven team transforming how medical devices reach the market - in an industry where quality, compliance, and patient safety mean nothing can be left to chance.
• Compensation & growth: Competitive salary plus equity, giving you a stake in the success you help create.