Regulatory Affairs Specialist - Med Devices & SaMD

Regulatory Jobs; Redmond (WA); Hybrid; USD 110.000 - 183.000; Vollzeit

Benefits dieser Stelle

Hybrid work model

Zusammenfassung

Join Stryker's Medical Division in Redmond, Washington as a Staff Regulatory Affairs Specialist with a hybrid work setup. You will guide regulatory activities across product development, changes, and lifecycle management, collaborating with R&D, Marketing, and Manufacturing to ensure compliance and market availability.

Responsibilities include supporting regulatory submissions, strategy development for product changes, and ongoing regulatory compliance across a diverse product portfolio.

Qualifikationen

• Bachelor’s degree in a technical field related to regulatory affairs.
• 4+ years of regulatory affairs experience in a medical device, pharmaceutical, or highly regulated industry.
• Experience authoring and managing regulatory submissions, registrations, or product approvals.

Aufgaben

• Support regulatory assessments of proposed product changes with R&D, Marketing, and Manufacturing.
• Support sustaining regulatory activities across a complex product portfolio.
• Identify regulatory requirements and barriers to market access and product distribution.
• Develop regulatory strategies in response to product changes and evolving requirements.
• Evaluate regulatory classification, jurisdiction, and pathways for products.
• Prepare and submit regulatory filings in accordance with guidelines.
• Provide regulatory guidance for product development and lifecycle management.
• Interact with regulatory authorities during submissions, reviews, and approvals.
• Evaluate pre-clinical, clinical, manufacturing, and software changes for filing strategies.
• Maintain product registrations and update reports and notifications.
• Support development of procedures and training related to regulatory requirements.

Kenntnisse

Communication skills

Regulatory awareness

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Engineering/Science/Regulatory Affairs

Regulatory Affairs Certification (RAC) or related master's

Jobbeschreibung

Join Stryker's Medical Division in Redmond, Washington as a Staff Regulatory Affairs Specialist with a hybrid work setup. You will guide regulatory activities across product development, changes, and lifecycle management, collaborating with R&D, Marketing, and Manufacturing to ensure compliance and market availability.

Responsibilities include supporting regulatory submissions, strategy development for product changes, and ongoing regulatory compliance across a diverse product portfolio.