Senior Consultant And Regulatory Affairs Skaneateles

Title: Senior Consultant and Regulatory Affairs

Location: Skaneateles, New York 13153 | Onsite

Work Arrangement: Hybrid with the possibility of fully Remote

Duration: 8+ Months

Position Summary:

• Serve as the Regulatory Affairs core team representative for EU MDR compliance and lifecycle activities supporting our organization Connected Monitoring and Respiratory Health medical products, including associated software.
• Execute assigned regulatory activities, maintain documentation, assess product changes, and support cross-functional project teams.

Key Responsibilities:

• Serve as the RA core team representative for assigned Connected Monitoring and Respiratory Health products, including software.

• Execute EU MDR regulatory activities for product changes, technical documentation, submissions, and lifecycle maintenance.
• Assess product changes for EU MDR impact, identify compliance gaps and risks, and escalate issues as appropriate.
• Prepare, review, and maintain EU MDR technical documentation and regulatory deliverables.
• Develop clear regulatory assessments and justifications with support from senior RA staff as needed.
• Support interactions and responses to EU Notified Bodies and regulatory authorities, as required.
• Work with Engineering, Quality, Clinical, Medical, Marketing, and other functions to incorporate regulatory requirements into project deliverables.
• Manage assigned priorities and timelines and communicate regulatory risks and issues proactively.

Qualification & Experience:

PRIMARY REQUIREMENT:

• Strong, hands-on EU Medical Device Regulation (EU MDR) regulatory expertise.
• Demonstrated experience applying EU MDR requirements throughout the medical device product lifecycle.
• Experience with EU MDR technical documentation, change assessments, and Notified Body interactions.
• Regulatory experience with Connected Monitoring and/or Respiratory Health medical products, including software.
• Ability to interpret requirements, identify compliance risks, and prepare clear regulatory assessments and documentation.
• Ability to work independently on assigned activities while collaborating effectively within cross-functional core teams.
• Strong written and verbal communication skills.
• Bachelor's degree or country equivalent in a scientific, engineering, regulatory, or related discipline.
• Minimum 5 years of Regulatory Affairs or related medical device experience.
• Strong EU MDR experience required; experience with complex medical devices and medical device software preferred.