Regulatory Affairs Associate

Role: Regulatory Affairs Associate

Location: Skaneateles Falls, NY(Hybrid)

Duration: Long Term

Required Education

-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

-Experience with complex medical devices and medical device software

Required Skills

-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

Serve as the Regulatory Affairs core team representative for EU MDR compliance and lifecycle activities supporting Baxter 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.

Essential Duties and 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