Job Description

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 strategiesin 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 changesfor 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. Actual minimum and maximum may vary based on location.Individual pay is based on skills, experience, and other relevant factors.

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