Hybrid Senior Regulatory Affairs Specialist

at Stryker

• Job title: Senior Regulatory Affairs Specialist
• Job type: Full Time
• Experience level: Senior
• Salary: $88,800 - $142,300 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Redmond, United States

About the role

• Senior Regulatory Affairs Specialist managing product compliance within the Medical Division in a hybrid role. Supporting regulatory compliance activities and collaborating with multiple cross-functional teams in an FDA regulated context.

Responsibilities

• Support R&D, Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers
• Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
• Assist in the development of regulatory strategy and updates strategy based upon regulatory changes
• Evaluate proposed products for regulatory classification and jurisdiction
• Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
• Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines for required products
• Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
• Communicate and interact with regulatory authorities throughout the development and review process of a regulatory submission through appropriate communication tools
• Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategies (if appropriate) for changes that do not require submissions
• Identify, monitor, and submit applicable reports or notifications to regulatory authorities during the clinical research process
• Maintain current product registrations and assist with processing registration changes when required

Requirements

• Bachelor’s degree in an Engineering, Science, or equivalent field
• Minimum of 3 years of experience in an FDA or highly regulated industry required
• Minimum of 2 years in a Regulatory Affairs role required
• Preferred RAC certification or Advanced Degree (Masters in Regulatory Affairs)
• Previous experience with US Class II/III medical devices
• Experience authoring regulatory submissions for product approval
• Experience interacting with regulatory agencies

Benefits

• Eligible for bonuses
• Generally eligible for short-term and long-term financial incentives