Staff Regulatory Affairs Specialist (Hybrid)

Stryker•Redmond, WA

2d•Hybrid

About The Position

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.

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.

Nice To Haves

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.

Responsibilities

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.