Senior Regulatory Affairs Specialist - EU MDR

Job Description:

Serve as the Regulatory Affairs core team representative for EU MDR compliance and lifecycle activities supporting Client's 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:

This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.

• 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.

Qualifications:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.

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.

Education and/or Experience:

Include the education and/or experience that is necessary to perform the job satisfactorily.

• 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.