Product-/QA Specialist

About ViroGates

ViroGates A/S is a Danish in-vitro diagnostics company listed on Nasdaq First North Growth Market Copenhagen. The company’s mission is to shift healthcare from reactive treatment to proactive prevention through high-accuracy diagnostic tools that enable earlier intervention and better decision-making.

ViroGates’ proprietary suPARnostic® product portfolio is based on the suPAR biomarker, providing clinically validated insights into chronic inflammation and overall health risk. The technology is used across acute care and clinical triage, with a growing focus on preventive health, longevity, and wellness.

Executive Summary

ViroGates A/S is seeking a Product-/QA Specialist to combine product management of its suPARnostic® portfolio with management of the company's quality management system as the company scales. The role suits an experienced IVD or medical device professional who can balance speed of execution with regulatory rigour while safeguarding product quality and patient safety.

Key Responsibilities

Product Management

Drive product management of new and existing suPARnostic® products, including leading R&D projects and improving existing products

Maintain technical product documentation, including IFUs

Act as the primary contact to the contract manufacturer

Provide product‐related sales support and customer training, and forecast consumables

Quality Management System & Regulatory Compliance

Act as ViroGates’ Co-Management Representative and process owner for the quality management system

Maintain and continuously improve the QMS in line with ISO 13485 and applicable regulatory requirements (IVDR)

Control of documents and records

Plan, conduct and support internal and external audits

Verify and oversee product storage and shipping/transport conditions (temperature monitoring, deviation/excursion handling, review of transport and storage stability data)

Risk, Vigilance & Post-market Surveillance

Risk management and change control

Handle nonconformities, CAPAs and complaints, including review and trending

Manage vigilance and reporting to authorities

Post‐market surveillance and related processes

Management Reviews, Training & Supplier Quality

Prepare and participate in management reviews

Own training processes across the organisation

Manage supplier quality

Contribute to management reporting on quality and product performance

Candidate Profile

Experience & Expertise

Relevant degree within life sciences, biotechnology, biomedical engineering, bioanalytical or a similar field

Minimum 5 years’ experience from the IVD or medical device industry, including product management and/or R&D

Documented experience as a QA Specialist / Management Representative and solid working knowledge of ISO 13485 and IVDR

Hands‐on experience with core QMS processes (document control, audits, CAPA, complaints, risk management and post‐market surveillance) and with technical product documentation and IFUs

Strong cross‐functional collaboration skills

Personal Attributes

Structured, detail‐oriented and quality‐minded

Able to balance speed of execution with regulatory compliance

Pragmatic and hands‐on, comfortable operating in a lean, fast‐moving organisation

Able to work across R&D, Sales & Marketing and external partners

Practical Requirements

Fluent in English (written and spoken); Danish is an advantage

Based at or able to work from ViroGates’ HQ in Birkerød

Willingness to travel up to 15 days per year

Organisation & Ways of Working

ViroGates operates with a lean organisation and a small, engaged team; the role reports directly to the QA & Product Manager. The culture is characterised by constructive collaboration, open dialogue and a strong focus on execution discipline. This role suits someone who enjoys end-to-end ownership rather than a narrow, siloed function.

Why Join ViroGates

Opportunity to work with both product and quality for a differentiated biomarker platform with strong clinical validation and multiple commercial applications

High degree of influence relative to organisation size, with direct access to management and decision‐making

A pivotal, cross‐functional role at a listed diagnostics company entering the fast‐growing longevity and preventive health markets

Collaborative, non‐hierarchical working environment with an entrepreneurial mindset

contact

Anna Nilsson - Founder, CEO & rekrutteringsekspert hos Hird Consulting.

Anna Nilsson

Founder, CEO

anna@hirdconsulting.dk