Siemens Healthineers·3 days ago
3 days ago
Senior Regulatory Affairs Specialist
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What you'll do
- Lead regulatory submissions for Radiation Oncology products
- Drive cross-functional collaboration
- Develop regulatory strategies
- Provide actionable guidance on complex global requirements
What they're looking for
- regulatory submissions
- medical device submissions
- fda 510(k) submissions
- ide submissions
- q-submissions
- health canada medical device license applications
- eu mdr technical documentation
- ce marking
- iso 13485
- iso 14971
- iec 62304
- iec 62366
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions for Radiation Oncology products. Drive cross-functional collaboration, develop regulatory strategies, and provide actionable guidance on complex global requirements. Ideal for experienced regulatory professionals with strong judgment and expertise in medical device submissions.
Skills
- regulatory submissions
- medical device submissions
- fda 510(k) submissions
- ide submissions
- q-submissions
- health canada medical device license applications
- eu mdr technical documentation
- ce marking
- iso 13485
- iso 14971
- iec 62304
- iec 62366
- electrical safety standards
- regulatory strategy
- pathway development
- risk assessment
Company
Siemens Healthineers
Palo Alto, United States of America
Company facts come from this company's own listings. We only show what the postings themselves carry.