Job Details
Location:
Graz, Austria (Hybrid / Flexible Framework)
Employment Type:
Full-time (38.5 h/week)
Current Phase:
Pre-Market / Mid-MDR Certification Audit
Core Toolkit:
EN ISO 13485:2016/A11:2021, MDR 2017/745 (Including Article 15)
Reporting Structure:
Flat hierarchy, direct collaboration with the engineering and data science roundtables
About Us & Our Core Dynamic At Combyn Health Care, we are a fast-moving, flat-hierarchy startup redefining preventive health monitoring. Our breakthrough platform, BioCore Loop, is an autonomous screening lounge that concurrently captures multi-modal physiological datasets, including raw ECG curves, Segmental Bioelectrical Impedance (BIA) waves, weight, and 3D body volume data, and streams them directly to the cloud for heavy-lifting algorithmic processing.
We don't do rigid corporate silos, endless management layers, or passive checkbox compliance. We are currently in the thick of our
MDR Class IIa certification process. We build real, life-saving hardware-software ecosystems, move at high velocity, and need a hands‑on quality leader who wants to ditch corporate red tape and make an immediate structural impact.
The Mission: Proactive Quality Driver We are not looking for a passive administrator or an archive keeper.
We need a proactive driver.
In a pre-market startup environment, developers and data scientists move fast. Your role is to sit at the table with them and aggressively but collaboratively pull regulatory compliance into our daily sprint cycles.
You will directly own our ongoing
MDR Technical Documentation submission, immediately closing documentation gaps flagged by our auditor (including software safety rationales, software architecture specifications, and complete software requirements formalization per EN 62304). By leveraging
Dot Compliance
as our centralized eQMS, you will automate the paper trail and ensure the team remains continuously audit-ready without sacrificing startup velocity.
Key Responsibilities & Duties
Drive Engineering Compliance:
Actively push and guide data science and software engineering team members to write technically specific, verifiable documentation that cleanly maps onto EN 62304 and ISO 14971 frameworks.
MDR Certification Ownership:
Navigate and execute the remaining pre-market documentation milestones required to successfully clear our ongoing Notified Body technical file review for MDR Class IIa clearance.
Act as PRRC:
Assume the role of
Person Responsible for Regulatory Compliance (PRRC)
in accordance with Article 15 of MDR 2017/745, overseeing technical validation thresholds and batch releases.
eQMS Automation:
Take total ownership of our
Dot Compliance
platform to maintain seamless, digital-native document control, build dynamic trace matrixes, and keep the QMS entirely lean and scale-ready.
Audit & Validation Strategy:
Lead future QMS audits, manage our pre-market CAPA and non-conformance trackers, and actively align with cloud engineers to verify secure data encryption and cybersecurity baselines.
Your Profile (Requirements & Competencies)
Pre-Market Mileage:
You have successfully shepherded a medical device or software platform through a complete Notified Body or third-party audit lifecycle. You know how to build compliance structures from scratch.
Proactive Assertiveness:
You possess exceptional interpersonal skills and a high degree of critical thinking. You don’t wait for people to hand you files; you proactively follow up with engineers, translate regulatory needs into clear actions, and push the team to achieve compliance milestones.
Regulatory Fluency:
Complete, hands‑on mastery of
EN ISO 13485:2016/A11:2021 ,
MDR 2017/745, and medical software lifecycle standards ( EN 62304 / ISO 14971 ).
eQMS Proficiency (A Major Plus):
Practical experience working inside
Dot Compliance
or an equivalent cloud-based electronic Quality Management System. You know how to use digital architectures to eliminate administrative overhead.
Languages:
Professional fluency in English is mandatory for our global market strategy; working knowledge of German is a strong asset for managing regional authority interfaces and Austrian supplier ecosystems.
What We Offer
Absolute Strategic Autonomy:
No multi-layered corporate approval loops or bureaucratic red tape. You are the ultimate authority on our regulatory execution.
A Sandbox for Innovation:
A close-knit, highly driven technical team where your regulatory blueprints directly unlock the international commercial launch of BioCore Loop.
Modern Work Agility:
Highly accommodating hybrid working models that adapt to your personal output and lifecycle.
Compensation:
Competitive startup salary package (gross minimum starting rate according to the collective agreement is
€ 60.200/year, with a distinct readiness to overpay significantly to secure the proactive driver we need).
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