8 Jobs in Saint Paul, MN
Axelon Services Corporation is Hiring a Senior Regulatory Affairs Specialist Near Saint Paul, MN
Location: Saint Paul, MN
Hours: 8:00 am - 5:00 pm
Role Overview:
- Perform assigned regulatory activities including submissions/responses to country authorities.
- Plan and prepare documents for EU MDR Technical File original submissions or responses to Notified Body for existing Technical Files under review.
- Assist in strategy implementation and operations for regulatory affairs activities, including development of EU MDR Technical File submissions and responses to Notified Bodies.
- Assist in maintaining Regulatory records and files.
- Review product changes as assigned and assess required EU MDR submissions/notifications.
- BA Degree, preferably in a science, engineering or technology discipline.
- 5 plus years of experience with EU MDR and the other skills listed if no BA degree.
- 3-5 years experiences in Medical Device Regulatory Affairs.
- Strong oral communication and interpersonal skills.
- Proficient in technical writing.
- Excellent organizational ability, capability to manage multiple, dynamic projects simultaneously.
- MS Office Suite including an intermediate level with Excel using Pivot Tables, creating trackers in Excel and monitoring these/conditional formatting.
Job Summary
Other
$95k-121k (estimate)
06/02/2024
09/22/2024
axelon.com
New York, NY
500 - 1,000
Related Companies
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