Regulatory Affairs Specialist III

Duration: 6+ Months

Summary Description

1. Independently provide EU regulatory requirements and guidance to EU MDR project teams.
2. Lead the preparation of the EU MDR technical documentation for Class III, IIa, IIb, or Class I sterile or reusable medical devices to support timelines for CE marking and EU commercial release.
3. Lead the submittal of the EU MDR technical documentation for Class III, IIa, or IIb medical devices and collaborate with the cross-functional team and Notified Body to respond to any questions during the review.

Supervision Received

• Under minimal supervision of Sr. Manager or Director of Regulatory Affairs

Supervision Exercised

• None

Essential Duties And Responsibilities

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• Primary responsibilities are to:
• Serves as the Regulatory Affairs lead on cross-functional MDR project teams.
• Ensures compliance with EU Medical Device Regulations (MDR) and EU guidance throughout the project.
• Actively participates in EU MDR project teams by attending meetings, collaborating with the project manager and cross-functional team members, and communicating regulatory requirements and guidance for the technical documentation.
• Review change orders associated with the MDR project deliverables.
• Writes and assembles information necessary for the technical documentation and works with the publishing department to finalize submission.
• Leads the preparation of the General Safety and Performance Requirements (GSPR) with the cross-functional team.
• Prepares and submits EU MDR technical documentation submission for applicable device per project schedule.
• Collaborates with the cross-functional team to respond to requests from EU Notified Body during the MDR technical documentation review.
• Prepares regulatory strategy to globally communicate and assess changes in scope of MDR project.
• Helps provide solutions to problems of moderate scope and complexity.

Desired Minimum Qualifications

• Bachelor’s degree in science, Engineering, Regulatory Affairs, or other technically related field.
• Minimum of 3-5 years regulatory experience in a regulated industry such as Medical Devices, Biotech or Pharma
• Excellent written and verbal communication skills.
• Experience in the preparation and submission of EU MDR technical documentation submissions, including EU Class II and III devices.
• Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to MDR project teams.

Tools And Equipment Used

Normal office environment: must be computer literate and familiar with Microsoft Suite of Products including Word, Excel, Outlook or similar.

Education:

Associate Degree

Shift:

1st shift