Siemens Healthineers·1 month ago
1 month ago
Senior Regulatory Affairs Specialist
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What you'll do
- Prepare and maintain regulatory submissions
- Guide new product development
- Ensure compliance with medical device regulations
What they're looking for
- Expertise in IVDs or medical devices
- Strong organisational and communication skills
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Exciting opportunity for a Senior Regulatory Affairs Specialist to prepare and maintain regulatory submissions, guide new product development, and ensure compliance with medical device regulations. Ideal for an experienced professional with expertise in IVDs or medical devices and strong organisational and communication skills.
Skills
- regulatory affairs
- fda 510(k) submissions
- ivdr class c recertifications
- quality management system (qms)
- technical files
- gmp environment
- outlook
- sharepoint
- microsoft office
- excel
- azure devops
- intercultural sensitivity
- presentation skills
- team orientation
- attention to detail
- multi-tasking
- regulatory compliance
Company
Siemens Healthineers
Ottawa, Canada
Company facts come from this company's own listings. We only show what the postings themselves carry.