Regulatory Affairs Contractor
Prepare and submit US FDA 510k applications and global regulatory documentation for medical devices
Support EssilorLuxottica in preparing and submitting US FDA 510k applications and global regulatory documentation, including EU MDR Class IIa readiness, with a focus on medical devices. Work remotely on a contract basis, 8-4 PM EST, with hours varying from 20-40 per week depending on project status.
Why This Role?
Work on real-world medical device regulatory projects with clear deliverables
Key Responsibilities
- Prepare and submit US FDA 510k applications
- Develop global regulatory documentation for EU MDR Class IIa readiness
- Collaborate with cross-functional teams to ensure regulatory compliance
- Monitor project timelines and adjust workload accordingly
- Stay updated on regulatory guidelines and requirements
- Maintain accurate records and documentation
Requirements
- Experience in regulatory affairs for medical devices
- Knowledge of US FDA 510k and EU MDR regulations
- Strong written and verbal communication skills
- Ability to work independently and manage multiple projects
- Proficiency in regulatory submission software
- Understanding of medical device development processes
Required Skills
Indonesia Context
- Working Hours Overlap:
- Minimal overlap — opposite hours
Keywords
View Original Description from Adzuna
Original description from Adzuna
Title: Regulatory Affairs Contractor Location: Remote Compensation: $100/hr on W2 Schedule: 8 - 4 pm EST, 20-40 hr/week, depending on project status Contract Length: 6 to 12 months of contract (depending on FDA review timelines) Start date: ASAP GENERAL FUNCTION EssilorLuxottica is seeking an experienced Regulatory Affairs contractor to support the preparation and submission of a US FDA 510k and the development of global regulatory documentation, including EU MDR Class IIa readiness and technic…
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