Staff Regulatory Affairs Specialist, Medical Devices

Stryker; Redmond (WA); Vor Ort; USD 110.000 - 183.000; Vollzeit

Zusammenfassung

Stryker's Medical Division in Redmond, WA is seeking a Staff Regulatory Affairs Specialist to guide regulatory activities across product development, changes and lifecycle management. You will partner with cross-functional teams to ensure compliance and market availability in a dynamic, highly regulated environment.

Responsibilities include supporting R&D, Manufacturing, and Marketing with regulatory assessments, developing strategies, preparing filings, and interacting with regulatory

Qualifikationen

• Bachelor’s degree in Engineering, Science, Regulatory Affairs or related field.
• Minimum 4 years of Regulatory Affairs experience in medical devices, pharma or similar.
• Experience authoring and managing regulatory submissions, registrations, or product approvals.

Aufgaben

• Support R&D, Marketing, and Manufacturing with regulatory assessments of proposed product changes, software updates, and transfers.
• Sustain regulatory activities across a complex product portfolio to ensure ongoing compliance and availability.
• Identify regulatory requirements and barriers to market access for products.
• Develop regulatory strategies for product development, lifecycle management, and changes.
• Evaluate regulatory classification, jurisdiction, and applicable filing pathways.
• Prepare and submit regulatory filings per agency guidelines.
• Provide regulatory guidance throughout product development and changes.
• Communicate with regulatory authorities during submissions and approvals.

Kenntnisse

Regulatory Affairs

Regulatory submissions

Communication

Ausbildung

Bachelor’s degree in Engineering/Science/Regulatory Affairs

Jobbeschreibung

Stryker's Medical Division in Redmond, WA is seeking a Staff Regulatory Affairs Specialist to guide regulatory activities across product development, changes and lifecycle management. You will partner with cross-functional teams to ensure compliance and market availability in a dynamic, highly regulated environment.

Responsibilities include supporting R&D, Manufacturing, and Marketing with regulatory assessments, developing strategies, preparing filings, and interacting with regulatory