Senior Regulatory Affairs Associate

Looking for a Senior Regulatory Affairs Associate with experience in medical devices

This Jobot Job is hosted by: Emmet Nitto
Are you a fit? Easy Apply now by clicking the "Apply on company site" button and sending us your resume.
Salary: $80,000 - $115,000 per year

A bit about us:

Based in Madison, WI, we are a a digital health solutions company advancing care and developing novel digital therapeutics. We are looking for a Senior Regulatory Affairs Associate to join our growing team!

Why join us?

• Competitive Salary!
• Great Benefits Package!
• The Opportunity to Join an Amazing Team!

Job Details

• BA/BS or MS degree in health or science related discipline
• Five to ten years of professional experience in submitting medical device products for regulatory approval
• Experience in regulatory strategies, product development, GMP, and regulatory submissions and registrations including but not limited to FDA and EU
• Extensive experience in medical device regulations include the US and EU regulatory requirements
• Experience with medical device standards and guidance's such as ISO 14971, ISO 14155, IEC 62304, EN 62366, etc., a plus
• Experience with clinical investigation, a plus
• Responsible for developing, writing and implementing regulatory strategy for assigned projects
• Provides advice and support to project teams for regulatory operations aspects of projects ensuring adherence and compliance. Actively drives interactions with regulatory bodies as assigned
• Provides regulatory support for EU Technical Files conforming to EU MDR

Interested in hearing more? Easy Apply now by clicking the "Apply on company site" button.