Staff Regulatory Affairs Specialist (Hybrid)

$110.1k - $183.4k

Stryker Corporation

Staff Regulatory Affairs Specialist position at Stryker's Medical Division in Redmond, Washington, supporting emergency care product development and lifecycle management. The role involves guiding regulatory activities, managing compliance, and partnering with cross-functional teams on product strategy and market access.

Responsibilities

Support R&D, Marketing, and Manufacturing with regulatory assessments of product changes and software updates
Maintain sustaining regulatory activities ensuring compliance and product availability across complex portfolio
Develop and refine regulatory strategies in response to product changes and evolving requirements
Prepare and submit regulatory filings and communicate with regulatory authorities throughout approval processes
Evaluate pre-clinical, clinical, manufacturing, and software changes to recommend filing strategies

Requirements

Bachelor's degree in Engineering, Science, Regulatory Affairs, or related technical field
Minimum 4 years regulatory affairs experience in medical device, pharmaceutical, or highly regulated industry
Experience authoring and managing regulatory submissions, registrations, or product approvals
Strong communication skills explaining regulatory requirements to technical and non-technical audiences
Experience with Class II and/or Class III medical devices (preferred)
Software as a Medical Device (SaMD) product support experience (preferred)
Regulatory Affairs Certification (RAC) or master's degree in regulatory affairs (preferred)

Compensation: $110,100 - $183,400 USD Annual

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Vacancy posted 13 days ago

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