Regulatory (GxP) Compliance Engineer

Regulatory (GxP) Compliance Engineer
Dassault Systmes, the 3DEXPERIENCE Company, provides business and people with virtual universes to imagine sustainable innovations. Its world-leading solutions transform the way products are designed, produced, and supported. Dassault Systmes collaborative solutions foster social innovation, expanding possibilities for the virtual world to improve the real world. The group brings value to over 190,000 customers of all sizes, in all industries, in more than 140 countries. For more information, visit www.3ds.com.This position can be based in Stockholm, Gothenburg, s-Hertogenbosch, or the UK.

Role & Responsibilities
. Be a part of our Quality Compliance and Continual Improvement team within our global Research & Development organization. Help run our global GxP compliance & readiness of 3DEXPERIENCE platform on the cloud. Use your data analysis and business skills to assess the compliance and effectiveness of our management systems and to objectively demonstrate compliance and drive continual improvement.

• Analyze and understand the cloud compliance landscape:
  • Cloud customer expectations
  • Industry expectations and regulatory enablement
  • Competitive landscape
  • Quality standards, certifications, frameworks
  • Information security & privacy standards and frameworks
• Regulatory Knowledge:A strong understanding of GxP regulations (such as GMP, GCP, and GLP) and guidelines from regulatory bodies like FDA, EMA, and ICH. This includes knowledge of industry-specific regulations and standards.
• Risk Management Expertise:The ability to identify, assess, and mitigate compliance risks related to systems, processes, and data. Familiarity with risk assessment frameworks is key.
• 
  Documentation and Validation Skills:Experience in creating, managing, and reviewing detailed documentation, including validation protocols, reports, SOPs, and audit trails. Knowledge of CSV (Computer System Validation) is often critical.
• Auditing and Inspection Readiness:Skills in conducting internal audits and preparing for external regulatory inspections. This includes managing CAPAs (Corrective and Preventive Actions) and addressing compliance gaps effectively.
• Communication and Training:Strong communication skills to coordinate with cross-functional teams, provide training on GxP principles, and effectively communicate compliance expectations to stakeholders.
• Customer Facing:Strong interpersonal and communication skills to liaise with customers, understand their compliance needs, and ensure alignment with GxP standards. The ability to explain complex regulatory requirements in a customer-centric manner is crucial.
• Develop, maintain, and improve internal compliance processes and procedures.
• Represent R&D on compliance topics with internal and external parties.

• Qualifications/Experience

  • Bachelors or Masters degree
  • 3-5 years of relative experience in the area of Life Science & Health Care.
  • Software development lifecycle (SDLC) methodologies and best practices
  • Quality management practices and standards

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    Software testing and quality assurance best practices
  • Program and project management methodologies and best practices
  • Industry regulations and compliance expectations for software providers (e.g., GxP regulations for life sciences)
  • Risk assessment methodologies and best practices
  • Experience with the following:
    • Program and Project Management
    • Continuous Improvement / Process Improvement
    • Risk Management
    • Change Management
    • Customer Relationship Management
  • Excellent English language communication, verbal and grammatical skills
  • Proficient with Microsoft Office Professional (PowerPoint, Word, Excel, Outlook, etc.)
  • Familiarity with information security management best practices and controls including ISO 27001, ISO 27701, SOC 2- desired

  
  As a game-changer in sustainable technology and innovation, Dassault Systmes is striving to build more inclusive and diverse teams across the globe. We believe that our people are our number one asset and we want all employees to feel empowered to bring their whole selves to work every day. It is our goal that our people feel a sense of pride and a passion for belonging. As a company leading change, its our responsibility to foster opportunities for all people to participate in a harmonised Workforce of the Future.