Hybrid Senior Regulatory Affairs Specialist

at Stryker

• Job title: Senior Regulatory Affairs Specialist
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Flower Mound, United States

About the role

• Senior Regulatory Affairs Specialist in the Endoscopy Business Unit. Supporting global regulatory strategies and compliance for medical devices based in Flower Mound, Texas.

Responsibilities

• Support new product development and sustaining for both US and OUS global regulatory release through the development and execution of regulatory strategies.
• Support the total product lifecycle by assessing changes made to the device post-launch to determine the regulatory impact of changes.
• Ensure regulatory compliance through the maintenance of regulatory documentation and support review by FDA, Notified Bodies and other regulatory bodies.
• Evaluate engineering changes to existing products to determine regulatory impact.
• Create and update regulatory deliverables as needed.
• Evaluate the regulatory environment and provide internal advice throughout the product lifecycle to ensure product compliance.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
• Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
• Evaluate proposed products for regulatory classification and jurisdiction.
• Provide regulatory information and guidance for product development and planning throughout the product lifecycle to regulatory groups and others within the organization.
• Identify the need for new regulatory procedures, SOPs, and participate in development and implementation.
• Help train stakeholders on current and new regulatory requirements to ensure organization wide compliance.
• Assist other departments in the development of SOPs to ensure regulatory compliance.
• Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
• Review collateral material associated with new launches and ongoing product support.

Requirements

• Bachelor’s degree (B.S. or B.A.) required
• 2+ years of working in an FDA regulated industry
• 2+ years of medical device regulatory affairs experience
• Previous experience with Class I and II Medical Devices
• Bachelor's degree in Engineering, Biological Sciences or equivalent focus
• RAC certification or Advanced Degree (Masters in Regulatory Affairs or Engineering)
• Previous experience with software Medical Devices
• Experience interacting with regulatory agencies
• Demonstrated success in management of global regulatory strategy and submission activities
• Applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations)
• Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements.