What are the responsibilities and job description for the Regulatory Affairs Specalist position at TekOne IT Services Pvt. Ltd.?
Job Title: Regulatory Affairs Specialist
Location: Irvine, CA 92614
Duration: 12 months
Support and maintain regulatory approvals for medical devices, ensuring compliance with global regulations.
Key Responsibilities
Location: Irvine, CA 92614
Duration: 12 months
Support and maintain regulatory approvals for medical devices, ensuring compliance with global regulations.
Key Responsibilities
- Collaborate with product development and manufacturing teams to provide regulatory guidance, resolve conflicts, and meet requirements.
- Prepare and manage submission documentation for global regulatory agencies and track milestones.
- Interact with regulatory bodies like the FDA, EU notified bodies, Japan PMDA, and others during submissions or audits.
- Advise on regulatory requirements and contingency planning.
- Monitor and assess global regulations, providing insights to expedite approval processes.
- Review labeling, product changes, and documentation to ensure regulatory compliance.
- Prepare and submit documents to international regulatory bodies.
- Experience with EU MDR and global regulatory bodies.
- Knowledge of Microsoft Office, Adobe, and product lifecycle management systems (Agile, Teamcenter).
- Experience with class II & III medical devices, product registration, license renewals, and FDA/EU audits.
- Manufacturing experience, especially OUS transfer solutions and compliance initiatives.
- Bachelor’s degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry).
- 2-4 years of experience in regulatory affairs, preferably in medical devices.
- Standard office hours, 5 days a week on-site.
- No travel involved.
- Experience with Ignite PLM (Teamcenter) and labeling software is preferred.
