Senior Regulatory Affairs Lead – MedTech (Hybrid)

Stryker; Redmond (WA); Hybrid; USD 96,000 - 160,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Wellbeing program

Job summary

Stryker's Medical Division in Redmond, Washington (Hybrid) is seeking a Senior Regulatory Affairs Specialist to support regulatory compliance and market access for medical devices across their lifecycle. You will collaborate with R&D, Marketing, and Manufacturing to assess changes and ensure proper submissions.

The role requires a Bachelor's degree in a technical field, at least 2 years of Regulatory Affairs experience, and knowledge of FDA/regulatory processes.

Qualifications

• Bachelor’s degree required. Preferred in Engineering, Science, Regulatory Affairs, or related technical field.
• Minimum of 2 years in a Regulatory Affairs role required.
• Experience in an FDA or highly regulated industry required.

Responsibilities

• Support regulatory assessments of proposed changes or product transfers with R&D, Marketing and Manufacturing.
• Identify requirements and obstacles for market access (federal, state, reimbursement).
• Assist in regulatory strategy updates based on regulatory changes.

Skills

Regulatory affairs

FDA/regulatory

Cross-functional collaboration

Regulatory submissions

Software as a Medical Device (SaMD)

Regulatory strategy

Education

Bachelor's degree (Engineering/Science/Regulatory Affairs)

Job description

Stryker's Medical Division in Redmond, Washington (Hybrid) is seeking a Senior Regulatory Affairs Specialist to support regulatory compliance and market access for medical devices across their lifecycle. You will collaborate with R&D, Marketing, and Manufacturing to assess changes and ensure proper submissions.

The role requires a Bachelor's degree in a technical field, at least 2 years of Regulatory Affairs experience, and knowledge of FDA/regulatory processes.