Solution Specialist

Grand Avenue Software; Polska; Hybrid; PLN 180,000 - 240,000; Full time

Benefits offered by this job

Hybrid/remote work environment

Travel to industry events

Professional development opportunities

Comprehensive benefits

Job summary

Grand Avenue Software is seeking an energetic quality professional to serve as the go-to expert for demonstrating and explaining our eQMS software to medical device manufacturers, with a focus on ISO 13485:2016 and MDSAP during live demos.

You will drive pre-sales activity, respond to RFIs/RFPs, run live demos, map regulatory requirements to software capabilities, guide compliance during implementation, and collaborate closely with sales teams to close deals and ensure smooth onboarding.

Qualifications

• 4+ years of hands‑on experience in quality assurance / quality systems within the medical device or life sciences industry.
• Direct work on ISO 13485:2016 compliant QMS and participation in or support of ISO 13485 and MDSAP audits.
• Ability to multi-task and manage technical and interpersonal functions in sales environments.
• Experience with eQMS platforms including the named systems or similar.

Responsibilities

• Deliver live and virtual product demonstrations tailored to ISO 13485:2016, MDSAP, FDA 21 CFR Part 820, and other compliance needs.
• Respond to RFIs/RFPs and answer detailed questions about software functionality, compliance mapping, validations, workflows, and integrations.
• Develop demo content, qualify opportunities with account teams, and address objections related to quality system requirements.
• Conduct gap analyses and compliance mapping to show audit readiness during sales and early implementation.
• Guide post-go-live success, address advanced questions, and optimize for compliance and ROI.
• Create sales enablement materials including demos, whitepapers, use-case examples, and knowledge base articles.
• Represent the company as a subject matter expert in webinars, trade shows, and industry events.

Skills

Quality assurance

ISO 13485:2016

MDSAP audits

eQMS platforms

Presentation skills

Sales support

Regulatory translation

Education

Bachelor's degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, or related field

Tools

Grand Avenue Software

Greenlight Guru

MasterControl

Qualio

ETQ

Job description

Do you want to leverage your deep domain expertise to help medical device companies succeed? We are looking for an energetic, knowledgeable quality professional to join our customer-facing team as the go-to expert for demonstrating and explaining our eQMS (electronic Quality Management System) software to medical device manufacturers.

You will play a pivotal role in the sales cycle by conducting compelling live product demos, addressing technical and compliance-related questions from prospects and sales reps, and supporting successful customer implementations. Your deep background in ISO 13485:2016 and MDSAP will help translate complex quality requirements into clear value propositions for our software.

This is an ideal position for someone who enjoys presenting to audiences, collaborating closely with sales teams, and using their regulatory and quality expertise to close deals and ensure smooth onboarding.

Key Responsibilities

Pre-Sales and Demo Support

• Deliver live and virtual product demonstrations of the eQMS platform to prospective customers and partners, tailoring each demo to highlight features that address ISO 13485:2016, MDSAP, FDA 21 CFR Part 820, and other relevant compliance requirements.
• Serve as the primary technical resource for the sales team by responding to RFIs/RFPs and answering detailed questions about software functionality, compliance mapping, validation, workflows, integrations, and best practices during sales calls, discovery sessions, and proof-of-concept evaluations.
• Partner with Account Executives and Sales Development Representatives to qualify opportunities, prepare demo scripts and content, and address technical objections related to quality system requirements.

Customer Implementation and Success

• Conduct gap analyses and compliance mapping sessions during sales and early implementation to demonstrate how the eQMS supports audit readiness and regulatory requirements.
• Guide post-go-live customer success by addressing advanced questions and recommending optimizations that maintain compliance and maximize customer ROI.

Thought Leadership and Sales Enablement

• Develop sales enablement materials, including demo decks, compliance whitepapers, use-case examples, and knowledge base articles grounded in real-world medical device scenarios.
• Represent the company as a subject matter expert in webinars, trade shows, and industry events to showcase the platform and generate leads.

Requirements

Required

• 4+ years of hands‑on experience in quality assurance / quality systems within the medical device or life sciences industry, with direct work on ISO 13485:2016 compliant QMS.
• Proven experience participating in or supporting ISO 13485 and MDSAP audits (as auditee, internal auditor, or consultant).
• Demonstrated ability to multi‑task, managing numerous technical and interpersonal functions simultaneously.
• Strong experience with eQMS platforms (implementation, configuration, or daily use of systems like Grand Avenue Software, Greenlight Guru, MasterControl, Qualio, ETQ, or similar).
• Excellent presentation and communication skills with a demonstrated ability to conduct engaging, technical live software demos to diverse audiences (e.g., QA managers, regulatory affairs, executives).
• Energetic, customer‑focused personality; comfortable in high‑interaction sales environments and patient when troubleshooting or explaining complex concepts.
• Ability to translate regulatory requirements into software benefits and value stories.
• Comfortable working in a fast‑paced, sales support role.

Preferred

• Bachelor's degree in Engineering, Life Sciences, Quality Management, Regulatory Affairs, or related field (not required; strong equivalent experience considered).
• Prior experience in pre‑sales, sales engineering, solutions consulting, application specialist or quality assurance roles supporting SaaS/regulated software.
• Strong experience with Grand Avenue Software
• Lead auditor certification (ISO 13485 or MDSAP) or training in progress.
• Familiarity with additional standards (e.g., FDA QMSR, EU MDR/IVDR, risk management per ISO 14971).
• Experience preparing for or responding to regulatory authority questions during sales cycles.
• Competitive base salary + performance incentives tied to sales success.
• Generous benefits package (various medical, dental, vision insurance plans, including fully employer paid for full family options; 401(k) with match; PTO; and hybrid/remote work environment)
• Opportunity to directly impact revenue growth while helping medical device companies achieve compliance more efficiently.
• Collaborative remote‑friendly environment with occasional travel for trade events and internal meetings.
• Professional development in both quality/regulatory and sales/technical demo skills.