Full-Time Senior Regulatory Affairs Manager

• 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
• Manage regulatory workflow
• Oversee progress and completion of projects
• Lead and coordinate internal tracking, authoring, and review of responses to requests from regulatory agencies
• Identify project risk and develop alternate strategies or contingency plans as mitigation
• Provide strategic advice to the cross-functional team
• Build and maintain a cooperative and respectful working environment
• Provide updates to project teams and management regarding regulatory status and requirements

• 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, including PMAs, sPMAs, 30-Day Notices, 510(k)s, and IDE submissions.
• Strong working knowledge of IVD and/or medical device development processes
• Proven ability to independently manage the preparation and coordination of premarket and post-market regulatory submissions.
• Successful track record of securing and maintaining product approvals and registrations
• Awareness of, and experience navigating, regulatory issues and challenges associated with diagnostic and/or IVD medical device development.
• Excellent analytical skills with high attention to detail.
• Strong written and verbal communication skills with the ability to convey complex issues in a straightforward manner.
• Highly organized and capable of managing multiple priorities across complex projects in a fast-paced environment.
• Self-motivated and able to work independently and collaboratively with minimal supervision.
• Hands-on, proactive, and solutions-oriented, with strong negotiation and interpersonal skills.

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