Hybrid Regulatory Affairs Specialist, Med Devices

Stryker Corporation; Redmond (WA); Ibrido; USD 110.000 - 183.000; Tempo pieno

Descrizione del lavoro

Stryker Corporation in Redmond, WA, is seeking a Staff Regulatory Affairs Specialist to guide regulatory activities across development, changes, and lifecycle management. You will collaborate with R&D, marketing, and manufacturing to ensure compliance and market availability.

You will assess regulatory requirements, develop strategies, and interact with regulatory authorities during submissions and approvals.

Competenze

• Bachelor’s degree required.
• Minimum 4 years of Regulatory Affairs experience.
• Experience with regulatory submissions and product approvals.
• Experience with SaMD and Class II/III devices is preferred.

Mansioni

• Support regulatory assessments of proposed product changes, software updates, and product transfers.
• Support sustaining regulatory activities across a complex portfolio to ensure ongoing compliance and market availability.
• Develop and refine regulatory strategies in response to product changes and evolving requirements.
• Prepare and submit regulatory filings per applicable requirements and guidelines.
• Provide regulatory guidance for product development, lifecycle management, and planned changes.

Conoscenze

Regulatory affairs

Regulatory submissions

Communication skills

Cross-functional collaboration

Formazione

Bachelor's degree

RAC certification

Master's degree

Descrizione del lavoro

Stryker Corporation in Redmond, WA, is seeking a Staff Regulatory Affairs Specialist to guide regulatory activities across development, changes, and lifecycle management. You will collaborate with R&D, marketing, and manufacturing to ensure compliance and market availability.

You will assess regulatory requirements, develop strategies, and interact with regulatory authorities during submissions and approvals.