2 Sr. Regulatory Affairs Specialist Jobs in Indianapolis, IN
Stark Associates LLC is Hiring a Sr. Regulatory Affairs Specialist Near Indianapolis, IN
- Independently provide EU regulatory requirements and guidance to EU MDR project teams.
- 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.
- 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 EXERCISED: None
Essential Duties And ResponsibilitiesTo 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 the 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 an 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 the scope of the MDR project
- Helps provide solutions to problems of moderate scope and complexity
- Bachelor's degree in Science, Engineering, Regulatory Affairs, or another 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 the scope of responsibility to provide regulatory input to MDR project teams.
Job Summary
Full Time
$87k-111k (estimate)
06/21/2024
07/18/2024
The job skills required for Sr. Regulatory Affairs Specialist include Regulatory Affairs, Verbal Communication, Technical Documentation, etc. Having related job skills and expertise will give you an advantage when applying to be a Sr. Regulatory Affairs Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Sr. Regulatory Affairs Specialist. Select any job title you are interested in and start to search job requirements.
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