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Why join Stryker?
Job description
Join Stryker's Medical Division supporting Emergency Care as a Staff Regulatory Affairs Specialist based in Redmond, Washington. In this role, you will help guide regulatory activities across product development, product changes, and lifecycle management while partnering with cross-functional teams to provide regulatory guidance and help ensure ongoing compliance and market availability.
What You Will Do
- Support R&D, Marketing, and Manufacturing teams with regulatory assessments of proposed product changes, software updates, and product transfers.
- Support sustaining regulatory activities across a complex portfolio of products, ensuring ongoing compliance, product availability, and implementation of product and process changes.
- Identify regulatory requirements and potential barriers to market access and product distribution.
- Develop and refine regulatory strategies in response to product changes and evolving regulatory requirements.
- Evaluate products for regulatory classification, jurisdiction, and applicable regulatory pathways.
- Prepare and submit regulatory filings in accordance with applicable regulatory requirements and agency guidelines.
- Provide regulatory guidance for product development, product lifecycle management, and planned product changes.
- Communicate and interact with regulatory authorities throughout submission development, review, and approval activities.
- Evaluate pre-clinical, clinical, manufacturing, and software changes and recommend appropriate regulatory filing strategies.
- Maintain product registrations and support required registration updates, reports, and notifications.
- Support the development of procedures, work instructions, and stakeholder training related to regulatory requirements and compliance activities.
What You Will Need
Required Qualifications
- Bachelor’s degree required. Preferred to be in Engineering, Science, Regulatory Affairs, or a related technical field.
- Minimum 4 years of experience in Regulatory Affairs within a medical device, pharmaceutical, biotechnology, or other highly regulated industry.
- Experience authoring and managing regulatory submissions, registrations, or product approvals.
Preferred Qualifications
- Experience with Class II and/or Class III medical devices.
- Experience supporting Software as a Medical Device (SaMD) products.
- Experience developing regulatory strategies for product development, lifecycle management, or product transfer activities.
- Regulatory Affairs Certification (RAC) and/or master's degree in Regulatory Affairs or a related field.
- Strong communication skills with the ability to explain regulatory requirements to technical and non-technical stakeholders.
US15: $110,100 - $183,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
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. Click here to learn more about: US Stryker employee benefits Stryker offers innovative products and services in MedSurg, Neurotechnology and Orthopaedics 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.
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