Hi, This is Harsha from Intellectt Inc. our medical device clients were in search of Regulatory Affairs Specialist in Mansfield, MA - 2048. if you are intrested please share me your updated resume to harsha@intellectt.com or give me a call back at +1 732-276-1830
Role: Regulatory Affairs Specialist
Location: Mansfield, MA - 2048
Duration: 8 Months
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 the 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.