Job Type
Job Details
We are currently seeking a Senior Regulatory Affairs Specialist to join our Medical Division to be based Hybrid Monday through Wednesday in Redmond, Washington.
What you will do
As part of the Medical Regulatory Affairs team, you will work with the team to maintain medical devices on the market and ensure ongoing compliance.
Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers
Identify regulatory and market access requirements, including federal, state/provincial, reimbursement, and purchasing group considerations
Develop and update regulatory strategies in response to evolving regulations and product development needs
Evaluate product classification and jurisdiction, and determine appropriate regulatory pathways and compliance requirements (local, national, international)
Prepare and submit regulatory submissions (electronic and paper) in accordance with applicable guidelines and maintain communication with regulatory authorities throughout the review process
Provide regulatory guidance throughout the product lifecycle, including development, planning, labeling, and claims, while maintaining current product registrations
Assess proposed pre-clinical, clinical, and manufacturing changes for regulatory impact and recommend filing strategies or alternatives when submissions are not required
Build relationships and interface with cross-functional teams (Engineering, International RA, Manufacturing, Marketing, etc.) to ensure accurate, complete, and timely submission preparation
What you need
Required
Bachelor’s degree in an Engineering, Science, or equivalent field
Minimum of 2 years of experience in an FDA or highly regulated industry
Minimum of 1 year in a Regulatory Affairs role
Preferred
RAC certification or Advanced Degree (Masters in Regulatory Affairs)
Previous experience with Class II/III medical devices
Experience authoring regulatory submissions for product approval
Experience interacting with regulatory agencies
$88,000.00 - $142,300.00 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
