Support regulatory strategy and compliance for medical device product development, software updates, product changes, transfers, and lifecycle management. Assess regulatory classifications and pathways, prepare submissions, maintain registrations, communicate with regulatory authorities, and guide R&D, marketing, and manufacturing stakeholders. The role also evaluates clinical, pre-clinical, manufacturing, and software changes and supports procedures, training, and ongoing market availability.
Work Flexibility: Hybrid
Travel Percentage: 10%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.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
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.
Travel Percentage: 10%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.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.
Similar Jobs
Healthtech • Other • Robotics • Biotech • Manufacturing
Supports regulatory activities for medical device product development, changes, transfers, lifecycle management, and market access. Evaluates regulatory classifications, jurisdictions, pathways, and product changes; prepares submissions and maintains registrations. Partners with R&D, marketing, manufacturing, and regulatory authorities while developing compliance procedures, training, and filing strategies. The role requires at least four years of regulatory affairs experience in a highly regulated industry, preferably involving Class II/III devices or SaMD.
Top Skills:
Software As A Medical Device (Samd)
Fintech • Information Technology • Insurance • Financial Services • Big Data Analytics
Manages strategic partnerships with benefits technology firms to drive sales growth, market expansion, partner enablement, data integration, and go-to-market initiatives. Owns partner relationships, develops joint business plans, coordinates cross-functional teams, manages pipeline development, and tracks performance metrics. Requires experience in group benefits or insurance distribution, benefits administration platforms, relationship management, and strategic stakeholder influence.
Top Skills:
AIAPIsBenefits Administration PlatformsHcm SystemsPayroll Systems
Fintech • Information Technology • Insurance • Financial Services • Big Data Analytics
Manages, grows, and retains large national employer accounts within group benefits. Owns client relationships and account strategy, drives profitable sales growth, manages broker and consultant relationships, assesses financial and underwriting risks, and coordinates cross-functional teams across sales, underwriting, service, and product functions. The role requires deep employee benefits expertise, complex deal negotiation, regulatory knowledge, relationship management, and attainment of insurance and FINRA licenses.
What you need to know about the Seattle Tech Scene
Home to tech titans like Microsoft and Amazon, Seattle punches far above its weight in innovation. But its surrounding mountains, sprinkled with world-famous hiking trails and climbing routes, make the city a destination for outdoorsy types as well. Established as a logging town before shifting to shipbuilding and logistics, the Emerald City is now known for its contributions to aerospace, software, biotech and cloud computing. And its status as a thriving tech ecosystem is attracting out-of-town companies looking to establish new tech and engineering hubs.
Key Facts About Seattle Tech
- Number of Tech Workers: 287,000; 13% of overall workforce (2024 CompTIA survey)
- Major Tech Employers: Amazon, Microsoft, Meta, Google
- Key Industries: Artificial intelligence, cloud computing, software, biotechnology, game development
- Funding Landscape: $3.1 billion in venture capital funding in 2024 (Pitchbook)
- Notable Investors: Madrona, Fuse, Tola, Maveron
- Research Centers and Universities: University of Washington, Seattle University, Seattle Pacific University, Allen Institute for Brain Science, Bill & Melinda Gates Foundation, Seattle Children’s Research Institute
