Staff Regulatory Affairs Specialist (Hybrid)
Stryker
Summary
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.
Job description
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.
Requirements
- 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.
- 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.
Company overview
Stryker is a global leader in medical technology, founded in 1941 by Dr. Homer Stryker and headquartered in Kalamazoo, Michigan. As one of the world's premier medical device companies, Stryker operates across three major business segments: Medical and Surgical Equipment, Orthopaedics and Spine, and Neurotechnology. The company impacts more than 150 million patients annually through its innovative products and services sold in over 75 countries worldwide. With approximately 53,000 employees globally and annual sales of $22.6 billion in 2024, Stryker maintains a strong commitment to research and development, investing $1.5 billion in R&D annually. The company's diverse portfolio includes surgical instruments, orthopedic implants, neurovascular devices, endoscopic systems, and advanced digital healthcare solutions. Stryker is recognized for its Mako robotic-assisted surgery systems and has been consistently ranked as one of Fortune's World's Best Workplaces for eight consecutive years, demonstrating its commitment to corporate culture and employee development.