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OOrbem
Orbem•Biotechnology

Head of Product Compliance

Location

Munich, Bavaria, Germany

Work type

Hybrid

Employment

Full Time

Experience

10-10 years

Compensation

€100K - €110K per year

Posted

8h ago

Summary and responsibilities

Role overview

Summary

Reporting directly to the Senior Director of Product, you will drive product quality management and regulatory compliance for Orbem’s cutting-edge systems across the EU, US, and other upcoming markets. You will serve as the strategic bridge connecting complex hardware, software, and AI capabilities with international safety and industry standards, leading and scaling the product compliance team.

Product Compliance & Quality Management Leader - Orbem

About the Role

Reporting to the Senior Director of Product, you will lead product quality management and regulatory compliance for Orbem's advanced hardware, software, and AI systems across the EU, US, and future markets. You will oversee global market approvals, scale the product compliance team, and ensure products meet international safety standards and internal quality requirements.

Responsibilities

  • Lead global compliance roadmaps, including NRTL approvals, CE marking, Machinery Regulation, and EMC Directive requirements.

  • Build, mentor, and scale the product compliance team while promoting ownership, continuous learning, and efficient delivery.

  • Collaborate with Product Development, Field Operations, Supply Chain, Procurement, and Legal to integrate quality and compliance throughout the product lifecycle.

  • Manage nonconformances, root-cause analysis, corrective and preventive actions (CAPA), risk assessments, technical documentation, and design improvements.

  • Translate complex regulatory requirements into practical guidance for cross-functional teams.

  • Optimize compliance frameworks and product validation processes for a fast-growing scale-up.

  • Oversee operator, installation, and maintenance manuals, safety markings, translations, and technical writing.

Requirements

  • 10+ years of experience in compliance and quality management, including leadership in a technology company or high-growth environment.

  • Experience managing complex hardware, software, and AI systems, ideally involving machinery or industrial automation.

  • Hands-on expertise in nonconformance management, CAPA, and root-cause analysis methods such as 8D, FMEA, and fault tree analysis.

  • Strong knowledge of international product compliance, including UL508A, NFPA 79, and CE marking under the Machinery Regulation and EMC Directive.

  • Experience integrating Design for Compliance and Design for Quality principles into product development and stage-gate processes.

  • Proven ability to build and lead technical teams.

  • Excellent cross-functional communication and stakeholder management skills.

  • Understanding of acceptance criteria, verification evidence, factory and site acceptance testing, calibration, and measurement traceability.

Preferred Qualifications

  • Experience with industrial automation in food processing or agriculture.

  • Degree in Electrical Engineering, Mechanical Engineering, or a related technical field.

Company Values

Orbem values ownership, continuous improvement, innovation, and building a sustainable future. The company encourages employees to embrace complex challenges, learn continuously, and explore new possibilities.

What Orbem Offers

  • Stock options and relocation support for Germany.

  • €1,750 annual learning and development budget.

  • Urban Sports Club or Wellpass fitness membership.

  • Childcare reimbursement and a Deutschland Ticket subsidy.

  • Flexible working hours and home office arrangements.

  • €185 home office allowance and an external monitor.

  • 30 days of paid leave and additional personal leave.

  • Work-from-anywhere flexibility for up to 60 days annually.

  • An international team representing 40+ nationalities across five continents.

  • Opportunities to lead projects, innovate, and make a meaningful impact in a fast-growing technology company.

Learn more about Orbem and its team at https://orbem.ai/company/

Orbem welcomes applications from candidates who may not meet every listed requirement but are excited about the role and its mission.

Updated 8h ago

Candidate fit

Skills and qualifications

Additional skills

Compliance Management • 1+ yrs
Quality Management • 1+ yrs
Regulatory Compliance • 1+ yrs
Leadership • 1+ yrs
Root-Cause Analysis • 1+ yrs
CAPA Processes • 1+ yrs
Cross-functional Collaboration • 1+ yrs
Stakeholder Management • 1+ yrs

Experience

10-10 years

How this role is positioned

Role classification

Job domains

Product

Industries

Healthcare & Pharma

Employment

Full Time

Contract duration

Permanent

Hiring type

Direct

Global hiring

Location specific

Offer details

Compensation and benefits

Compensation

€100K - €110K per year

VisibilityShared on listing
CurrencyEUR
PeriodYearly

Benefits and perks

Stock Options / ESOP
Learning & Development Budget

Location, schedule, and role shape

Work setup

Work conditions

Primary locationMunich, Bavaria, Germany
Work typeHybrid
Global hiringNo

Bandwidth profile

peopleHigh • 9/10
physicalLow • 2/10
cognitiveHigh • 8/10
executionHigh • 8/10
creativityMedium • 6/10
uncertaintyMedium • 7/10
communicationHigh • 9/10

Context on the employer

Company snapshot

Company

Orbem

Team size

Growing team

Location

Munich, Bavaria, Germany

Orbem uses AI to industrialize MRI, delivering non-invasive insight into everything from fruits to eggs to the human body. We are transforming what is becoming the world's largest biological dataset into actionable intelligence to reduce waste, increase quality, and accelerate the shift toward a more sustainable and healthier future.

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Head of Product Compliance

Munich, Bavaria, Germany • Full Time