Staff Regulatory Affairs Specialist (Hybrid)
$110.1k - $183.4kStryker
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
Vacancy posted 3 days ago
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