Staff Regulatory Affairs Specialist (Hybrid)

Stryker Group; 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

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.

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.

US15: $110,100 - $183,400 USD Annual

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