Jen Hughes
Regulatory Program Manager, Health at Apple
- Role
- Regulatory Program Manager at Apple
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Jen Hughes
I oversee and project manage regulatory and quality activities for new product development, clinical trials, market applications, and product launches for pharmaceutical and medical device products spanning various therapeutic areas and product categories. I have more than ten years of experience in global regulatory affairs, with expertise in medical device, in-vitro diagnostics (IVD), and pharmaceuticals.I am passionate about delivering high-quality and timely regulatory submissions, ensuring compliance with different regulatory requirements and standards. I have successfully managed and executed multiple regulatory submissions, approvals, and consultations in various regions, including US, Canada, EU, LATAM, and APAC. I have also contributed to business development, project management, staff training, and mentoring within my team and organization.
Experience
Regulatory Program Manager
Sep 2024 — Present
OUS EPM for Apple Health software as medical devices (SaMD)
Education
Concordia University-Wisconsin
Master of Business Administration (M.B.A.), Business Administration and Management, General
University of Wisconsin-Milwaukee
Bachelor’s Degree, Clinical Laboratory Science/Medical Technology/Technologist
University of Wisconsin-Milwaukee
Certificate, Healthcare Informatics
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