Stryker
Senior Regulatory Affairs Specialist (Hybrid)
Stryker, Redmond, Washington, United States, 98052
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. Individual pay is based on skills, experience, and other relevant factors.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
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. Individual pay is based on skills, experience, and other relevant factors.
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.