Regulatory Compliance Specialist

New

Skills

Clear Communication FDA Regulations IEC 60601 ISO 13485 ISO 14971 ISO Standards MDSAP Project Management Regulatory Compliance Regulatory Submissions

The Regulatory Specialist will oversee regulatory compliance for novel medical devices, ensuring that all products meet FDA and ISO standards. This role involves managing the regulatory submissions pipeline for OXOS products and monitoring national and global regulatory developments to inform strategic decisions.

Key Responsibilities
  • Oversee regulatory compliance for medical devices in accordance with FDA and ISO standards.
  • Manage the regulatory submissions pipeline for all OXOS products.
  • Monitor and analyze national and global regulatory developments.
  • Ensure all submissions are accurate, compliant, and submitted in a timely manner.
  • Collaborate with teams to inform strategy with Regulatory Affairs.
  • Plan regulatory strategies in coordination with Regulatory Affairs and Project Management Office (PMO).
Required Skills & Qualifications
  • Bachelor's degree or higher in a relevant field.
  • Regulatory experience with FDA-regulated medical devices.
  • Knowledge of MDSAP, ISO 13485, ISO 14971, and IEC 60601.
  • Strong attention to detail.
  • Excellent written and verbal communication skills.
  • Project management skills.

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Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: Months

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