Senior Consultant – Quality, Regulatory & Business Development

-About QUNIQUE-

QUNIQUE is a Swiss and German life science services company supporting medical device and in-vitro diagnostic manufacturers across their full product lifecycle – from quality management system set-up and technical documentation to audits, authorised representation (CH-REP / EC-REP) and regulatory compliance in Switzerland, the EU, the US and other international markets.

Role Purpose

As Senior Consultant you combine deep MedTech quality and regulatory expertise with a strong commercial mindset. You deliver high-quality consulting and audit engagements for our clients while actively growing QUNIQUE’s business – identifying opportunities, building lasting customer relationships and converting them into projects and recurring mandates.

Consulting & Auditing

• Review and implement quality management requirements according to EU MDR 2017/745, EU IVDR 2017/746, ISO 13485:2016 and MDSAP.

• Support clients with international market access, in particular US FDA requirements (21 CFR Part 820 / QMSR, 510(k), De Novo, PMA, UDI, MDR reporting under 21 CFR Part 803) as well as UK, Canadian and other MDSAP jurisdictions.

• Prepare gap analyses against legal and normative requirements and define pragmatic remediation plans.

• Draft and review technical documentation according to EU MDR / IVDR requirements and support the preparation of FDA submissions.

• Plan and conduct internal, supplier and mock audits in line with ISO 19011:2026, including FDA inspection and MDSAP audit readiness.

• Support clients in quality engineering, problem solving, CAPA and complaint handling.

• Manage local and international client projects – scope, timeline, budget and deliverables.

• Ensure all work is performed in accordance with applicable safety, quality and regulatory requirements.

Sales & Business Development

• Develop and maintain relationships with existing and potential customers, acting as a trusted advisor.

• Actively generate leads, qualify opportunities and prepare proposals and offers.

• Work toward agreed sales and revenue objectives and contribute to account planning and pipeline reporting.

• Build relationships with manufacturers, hospitals, clinics, medical professionals, distributors and other relevant organisations.

• Identify cross-selling opportunities across QUNIQUE’s service portfolio (consulting, audits, CH-REP / EC-REP mandates).

• Represent QUNIQUE at conferences, trade fairs, webinars and customer events, including public presentations.

Internal Contribution

• Prepare internal reports, presentations and business documents.

• Share market and regulatory insights with the team and contribute to the development of new services.

Must have

• Minimum 10 years of experience in the MedTech industry.

• Professional knowledge and experience with the requirements for medical devices, in-vitro diagnostic medical devices or combination devices.

• Experience in quality engineering, problem solving, complaint handling or equivalent.

• Auditor experience with proven qualification according to ISO 19011:2026.

• Solid knowledge of EU MDR 2017/745, EU IVDR 2017/746, ISO 13485:2016 and MDSAP, including gap analysis and technical documentation.

• Working knowledge of US FDA requirements for medical devices (21 CFR Part 820 / QMSR, 21 CFR Part 803, 21 CFR Part 11, premarket pathways 510(k), De Novo and PMA).

• Familiarity with ISO 14971:2019 risk management and IEC 62304 / IEC 62366-1 where applicable.

• Proven experience in managing local or international projects.

• Demonstrated success in business development, account management or consultative selling – ideally with a track record of meeting revenue targets.

• Excellent communication and negotiation skills; confident presenting to clients and in public.

• Strong organisational skills and ability to work independently.

• Fluent in English, written and spoken.

• Willingness to travel.

Nice to have

• German language skills (additional languages such as French or Italian are an advantage).

• Established network within the Swiss / European MedTech ecosystem.

• Experience with Swiss MedDO / IvDO and authorised representative (CH-REP / EC-REP) requirements.

• Knowledge of further international regulations, e.g. UK MDR 2002 (UKCA), Health Canada (SOR/98-282), Australia TGA, Japan PMDA, Brazil ANVISA, or China NMPA.

• Hands-on experience with FDA inspections, Warning Letter / 483 remediation or FDA submissions.

What We Offer

• A key role combining expert consulting with direct impact on company growth.

• A diverse client portfolio across medical devices and IVDs in Switzerland, the EU and international markets.

• A small, dynamic team with short decision paths and high autonomy.

• Performance-related compensation component linked to sales objectives.

• Continuous professional development and training opportunities.