About the role
Focus on regulatory compliance, EU MDR documentation, and technical documentation management to ensure compliance with market standards.
Responsibilities
- Create and update iTOCs in OnePLM in response to EEMEA GPRD and change requests.
- Assess documentation impact of design and drawing changes and reflect updates accurately in iTOCs.
- Ensure correct linking, versioning, lifecycle management, and routing of technical documentation.
- Collaborate with Engineering, Quality, and Regulatory stakeholders to deliver timely, compliant outputs.
- Support efficient request handling while maintaining strong documentation quality standards.
Full description
Job:- Regulatory Affairs
Exp- 4- 8 yrs
Please find the JD below.
The Regulatory Affairs Support role will provide temporary capacity to address increased EEMEA GPRD demand, with a primary focus on the creation and maintenance of iTOCs in OnePLM. The position supports EU MDR market continuity activities by ensuring accurate, timely, and high-quality technical documentation updates.
Key Responsibilities:
Create and update iTOCs in OnePLM in response to EEMEA GPRD and change requests
Assess documentation impact of design and drawing changes and reflect updates accurately in iTOCs
Ensure correct linking, versioning, lifecycle management, and routing of technical documentation
Collaborate with Engineering, Quality, and Regulatory stakeholders to deliver timely, compliant outputs
Support efficient request handling while maintaining strong documentation quality standards
Qualifications:
Hands-on experience with OnePLM, preferably including iTOC creation and maintenance
Familiarity with EU MDR technical documentation and controlled document practices
Ability to work efficiently in a high-volume, deadline-driven environment
Strong attention to detail and clear cross-functional communication skills
Early-career regulatory professional or equivalent experience preferred