What are the responsibilities and job description for the Regulatory Affairs Specialist position at TekOne IT Services Pvt. Ltd.?
- Technical File Revisions:
- Support the IVDR project by revising technical files using the latest templates.
- Ensure each file clearly presents the product, its characteristics, and expected performance to demonstrate evidence of conformity.
- Include the latest versions of required technical reports, validations, test reports, and other relevant documents.
- Complete assigned technical files within a predefined timeline and attend weekly meetings to address issues or questions.
- Keep the project manager informed on progress.
- IVDR Labeling Conversion:
- Support the IVDR labeling conversion project, including weekly meetings and cross-functional collaboration.
- Update the labeling conversion tracking log based on the monthly manufacturing schedule, product fill dates, lot numbers, and change request numbers.
- Update labeling specifications to ensure compliance with IVDR requirements.
- Un-CE Marking:
- Assist in un-CE marking selected products and track work until final labeling reflects changes.
- Ensure that updates align with the labeling specification document.
- Regulatory Notifications:
- Update the technical file tracking log and track regional regulatory notifications of labeling changes.
- Notify the RA SAP restriction coordinator when product lots need to be restricted to prevent distribution in specific regions.
- Miscellaneous Tasks:
- Complete other activities related to regulatory compliance as needed to support the project.
- Experience:
- Must have working knowledge of FDA and CE marking requirements for IVD (In Vitro Diagnostic) products.
- Experience with transitioning products from IVDD to IVDR is highly preferred.
- Strong technical writing and documentation skills.
- Education: Bachelor’s degree in a related field (e.g., Regulatory Affairs, Biomedical Engineering, or Life Sciences).
- Technical Skills:
- Experience with technical file preparation and revision.
- Knowledge of labeling specifications and regulatory conversion processes.
- Familiarity with IVDR compliance and labeling requirements.
- Strong project management and organizational skills.
- Communication Skills:
- Ability to work cross-functionally and attend multiple weekly meetings to track progress and address issues.
- Strong attention to detail in managing technical documentation and timelines.
Specialist - Premarket Regulatory Affairs
Applied Medical -
Rancho Santa Margarita, CA
