Senior Regulatory Affairs Associate
- Employer
- Jobot
- Location
- Madison
- Salary
- 80000.00 - 115000.00 USD Annual
View more
- Industry
- Government and Public Services
- Role
- Other
- Job Type
- Long-Term
- Hours
- Full Time
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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?
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!
- 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
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