Full-Time Senior Regulatory Affairs Manager - Screening

• Effectively prepare and manage FDA submissions.
• Represent regulatory affairs in cross-functional project teams.
• Actively review project and submission related documentation.
• Support regulatory activities throughout product lifecycle.
• Facilitate product approvals through effective communications.
• Support the planning and execution of the regulatory strategic direction.

• Bachelor’s degree in Life Sciences, Engineering, or related discipline with at least 7 years of relevant regulatory affairs experience.
• Proven success in authoring and leading FDA regulatory submissions and interactions.
• Strong working knowledge of IVD and/or medical device development processes.
• Excellent analytical skills with high attention to detail.
• Self-motivated and able to work independently and collaboratively with minimal supervision.

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