Senior Regulatory Affairs Manager - Remote

Overview

The Senior Regulatory Affairs Manager will oversee North America regulatory activities, ensuring compliance for in vitro diagnostic devices while supporting cross-functional project teams.

In Short

• Manage regulatory activities for IVD products in North America.
• Prepare and complete technical file submissions.
• Develop regulatory strategies for product submissions.
• Assess changes affecting IVD products and communicate impacts.
• Support global regulatory teams with registrations.
• Maintain knowledge of IVD regulations and guidance.
• Provide input on clinical study protocols.
• Support CE marking and market clearance activities.
• Review promotional materials and product labeling.
• Participate in import/export permitting activities.

Requirements

• Bachelor's Degree in a STEM field.
• 6+ years of regulatory experience or 4+ years with advanced degree.
• Excellent understanding of regulations in the Americas.
• RAC certification preferred.
• Strong communication skills in English.
• Excellent time management and organizational skills.
• Ability to work independently and in a team.

Benefits

• Medical, Dental, and Vision Insurance Options.
• Life and Disability Insurance.
• Paid Time-Off.
• Parental Benefits.
• 401k with Company Match.
• Employee Stock Purchase Plan.