Sr. Specialist Regulatory Affairs

仕事内容

• Manage and/or prepare device regulatory filings with a thorough understanding of the US FDA and EU (MDD/MDR) regulatory requirements.
• Review and access process and/or design change controls for potential impact on current medical device regulatory filings.
• Provides high quality regulatory support for assigned products/projects.
• Works in close collaboration with internal stakeholders and supports multiple projects.
• Provides support as needed for non-project related "regulatory excellence" activities.
• Ensures compliance with global regulatory requirements and adherence to internal policies and processes.
• Responds to regulatory requests from across the organization in a timely manner.
• Provides high quality regulatory support for assigned products/projects.
• Partners with internal stakeholders (e.g., regions) to align on regulatory strategy in order to achieve business objectives.
• Develops training programs for internal stakeholders, as needed.
• Develops documents that are clear, concise, and complete to facilitate reviews/approvals.

• Written and verbal English communication skills are required.
• Bachelor Degree and at least 4 years of relevant experience OR Master Degree with 2 years related experience
• Experience within Medical Devices industry preferred