Regulatory Affairs Specialist II
Alamedaonsitemid$90K – $125K
Posted 1mo ago · via Lever
About this role
In this role, you will work with the team that ensures that Penumbra products are approved for use in countries around the world, thereby helping to bring our life-saving technologies to patients worldwide. You will be responsible for the coordination, preparation, and maintenance of document packages for worldwide regulatory submissions.
What You’ll Work On
• Under direct supervision, prepare moderately complex submissions to gain approvals for clinical research, export, and commercial distribution, such as: IDE, 510(k), CE-Mark Technical Dossier, UKCA Mark, other regional Regulatory submissions, non-US Clinical Trial Submission, Shonin, and Certificates to Foreign Government
• Track multiple projects concurrently
• Ensure that existing approvals and documentation are maintained…
What we'd score you on
reqspace match rubricFive dimensions, recruiter-grade. Upload your resume and we'll generate a written explanation of where you fit and where the gaps are.
1
Skills match
We compare your skills against the role requirements.
2
Level fit
This role is mid-level. We check your trajectory against it.
3
Domain experience
Your work in the role's domain matters more than your years total. We weight recent and direct experience.
4
Recency
A skill you used last quarter weighs more than one from five years ago. We grade on recency, not lifetime.
5
Location fit
This role is based in Alameda. We weight your proximity and willingness to relocate.
Score yourself on this role.
Free · no card · written explanation included
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