(Senior) Regulatory Affairs Expert & Industry Representative (w/m/d)

July 14, 2026

open role

About Us Confideck builds software for one of the most complex and impactful industries: MedTech and Pharma.

Our platform helps manufacturers create, maintain, review, and control technical documentation in a structured, validated, and audit-ready environment. Instead of managing isolated documents, Confideck connects regulatory information across the technical file and automates recurring documentation work.

We are a fast-growing SaaS company based in Vienna. Our team combines expertise in software development, product management, regulatory affairs, and technical documentation.

The role As our Senior Regulatory Affairs Expert & Industry Representative, you are Confideck's regulatory domain expert, trusted customer advisor, trainer, and external representative.

You work directly with Regulatory Affairs, Quality, and Technical Documentation teams at medical device and IVD manufacturers. You support customers from the identification of suitable use cases through onboarding, training, adoption, and ongoing platform use.

You also represent Confideck in webinars, conferences, partner events, and international industry discussions. Together with Confideck, you will build your profile as a recognised expert in technical documentation, regulatory automation, validation, and controlled AI.

Note: Native-level German and very good written and spoken English required.

Full-Time

Remote / Vienna, Austria

Customer advisory and enablement

Understand customers' documentation landscapes, regulatory requirements, systems, and operational challenges.

Help customers define suitable use cases and implementation scopes.

Advise customers on the automation of technical documentation.

Conduct onboarding sessions, platform trainings, and regulatory workshops.

Enable customer teams to use Confideck independently and successfully.

Act as a trusted regulatory sparring partner throughout implementation and ongoing use.

Build long-term relationships with customers and key stakeholders.

Regulatory expertise and product development

Support use cases such as document creation, maintenance, consistency reviews, change impact analysis, and submission preparation.

Understand the relationships between requirements, product information, risks, claims, evidence, testing, and technical documentation.

Help define controlled approaches for automation and AI-assisted documentation.

Bring customer feedback and regulatory expertise into product development.

Translate customer needs into clear use cases and requirements.

Review and test new functionality from a regulatory and customer perspective.

Support Sales and Customer Success in regulatory and technical discussions.

Industry representation and partnerships

Represent Confideck in webinars, conferences, panel discussions, and customer events.

Present regulatory and technical documentation topics to international audiences.

Contribute to expert formats with industry associations and certification bodies.

Collaborate with partners on webinars, content, customer projects, and market initiatives.

Build relationships with regulatory experts, industry stakeholders, and partner organisations.

Contribute to articles, guides, white papers, interviews, and presentations.

Actively build your professional expert profile together with Confideck.

What you bring

At least five (5) years of experience in Regulatory Affairs, Quality Management, or Technical Documentation for medical devices or IVDs.

Experience creating, maintaining, reviewing, or remediating technical documentation.

Confidence leading customer discussions, workshops, trainings, and webinars.

Strong presentation, facilitation, and communication skills.

The ability to explain complex regulatory requirements clearly and practically.

A customer-oriented mindset and a strong interest in software, automation, and controlled AI.

The ability to work independently and take ownership.

Native-level German and very good written and spoken English.

Willingness to travel occasionally.

Experience that makes you stand out

Experience in customer-facing regulatory or technical documentation roles.

Speaking experience at webinars, conferences, or industry events.

An existing network within the MedTech, IVD, or Regulatory Affairs community.

Collaboration with industry associations, notified bodies, certification organisations, or consulting partners.

Experience implementing regulatory, document management, PLM, RIM, or QMS software.

What is in it for you Take on a visible role at the intersection of Regulatory Affairs, software, automation, and AI. Work directly with leading MedTech and IVD manufacturers, and represent Confideck alongside customers, industry partners, associations, and certification organisations.

We Offer You

Participation in webinars, conferences, and international expert formats

The chance to build your professional profile alongside the Confideck brand

Influence on our customer approach and platform development

Close collaboration with our founders, customers, partners, product management, and software engineering

Remote work within DACH, competitive compensation, and our share option programme

How you work You combine regulatory credibility with a pragmatic and customer-oriented mindset. You enjoy translating complex requirements into practical solutions, are comfortable representing Confideck externally, and want to build a recognised expert profile in the regulatory community.

Hiring process

Introductory call with one of the founders

Practical customer-facing regulatory case, short presentation, or training exercise

Get to know the entire Confideck founding and core team

Contact Confideck GmbH

Diesterweggasse 31

1140 Vienna, Austria Bringing innovations to patients faster.

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