Senior Regulatory Affairs Specialist; Hybrid

Overview

We are currently seeking a Senior Regulatory Affairs Specialist to join our Endoscopy Business Unit based Hybrid in Flower Mound, TX.

As the Senior Regulatory Affairs Specialist you support new product development and sustaining for both US and OUS global regulatory release through the development and execution of regulatory strategies in accordance with applicable regulatory requirements. You support the total product lifecycle by assessing changes made to the device post-launch to determine the regulatory impact of changes. You will also ensure regulatory compliance through the maintenance of regulatory documentation and support review by FDA, Notified Bodies and other regulatory bodies.

You are viewed as the primary regulatory team resource.

• Evaluates engineering changes to existing products to determine regulatory impact. Creates and updates regulatory deliverables as needed
• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
• Evaluates proposed products for regulatory classification and jurisdiction
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
• Helps train stakeholders on current and new regulatory requirements to ensure organization wide compliance
• Assists other departments in the development of SOPs to ensure regulatory compliance
• Provides regulatory input and technical guidance on global regulatory requirements to product development teams
• Provides regulatory information and guidance for proposed product claims/labeling
• Review collateral material associated with new launches and ongoing product support.

Required

• 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

Preferred

• 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

Health benefits include:
Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.

Financial benefits include:
Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Stryker offers innovative products and services in Med Surg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.