🌎
This job posting isn't available in all website languages

Sr. Regulatory Affairs Specialist

📁
Regulatory Affairs
📅
20000C70 Requisition #
Thanks for your interest in the Sr. Regulatory Affairs Specialist position. Unfortunately this position has been closed but you can search our 1,863 open jobs by clicking here.

REQUIREMENTS:
Master’s degree in Regulatory Affairs, Biomedical Engineering or Biotechnology and two (2) years of experience in Regulatory Affairs and two (2) years of post-bachelor’s progressive experience in all of the following: US and EU submissions for Class III and Class II medical devices; Clinical investigation, clinical trial planning, clinical study designs, clinical protocol development, adverse event reporting for Class III and Class II medical devices; FDA requirements, guidance documents, Medical Device Directive, Food Drug and Cosmetic Act, ISO 14971 and ISO 13485; Establishment registration, Device listing and license renewal; US and international regulatory requirements including design control, manufacturing, marketing, labeling and promotion regulations; Coordinating manufacturing processes for regulatory strategy on existing product approval & registration.


My Profile

Create and manage profiles for future opportunities.

Go to Profile

My Submissions

Track your opportunities.

My Submissions

Similar Listings

Northridge, California, United States

📁 Regulatory Affairs

Requisition #: 20000A7J

Northridge, California, United States

📁 Regulatory Affairs

Requisition #: 200008P0

Northridge, California, United States

📁 Regulatory Affairs

Requisition #: 20000MIY

FORTUNE NAMES MEDTRONIC TO 'CHANGE THE WORLD' LIST

FORTUNE puts Medtronic among the top 20 companies worldwide having a positive social impact through core business strategy.

Read The Story

ENGINEERING

Bring your talents to help us build life-changing technology

LEARN MORE

Three Women Working

INCLUSION AND DIVERSITY

We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.

SEE HOW