Senior Regulatory Affairs Consultant

Job Title: Senior Consultant Regulatory Affairs

Location: New York/ Remote flexibility

Employment Type: Contract (W2)

Summary

Looking for a Regulatory Affairs Consultant with strong EU MDR experience to support regulatory compliance, product changes, and documentation for Connected Monitoring and Respiratory Health medical devices, including software.

Responsibilities

• Support EU MDR regulatory activities and product lifecycle management.
• Prepare and maintain EU MDR technical documentation.
• Assess product changes and identify regulatory compliance gaps.
• Support regulatory submissions and Notified Body interactions.
• Prepare regulatory assessments and justifications.
• Work with Engineering, Quality, Clinical, and other cross-functional teams.
• Track project timelines and communicate regulatory risks.

Requirements

• Bachelor's degree in Science, Engineering, Regulatory Affairs, or a related field.
• Minimum 5 years of Regulatory Affairs or medical device experience.
• Strong hands-on EU MDR experience.
• Experience with technical documentation and product change assessments.
• Experience with EU Notified Body interactions.
• Experience with connected medical devices or medical device software preferred.
• Strong written and verbal communication skills.

Pay Scale

Anticipated hourly pay range: 45/hr to $50/hr. (Depends on Experience)

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws