Job Description

About Stryker

Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

Stryker is one of the worlds leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Senior Regulatory Affairs Specialist to join our Communications Division to be based in Flower Mound, TX.

Who we want

* Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes finding ways to simplify, standardize and automate.

* Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams.

* Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

* Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

* Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

What you will do

As a Senior Regulatory Affairs Specialist, you support new product development 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 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.

What you need

* A minimum of a Bachelors degree required; Degree in Engineering, Life Sciences or similar preferred.

* A minimum 3 years of experience in a FDA regulated industry required; preferably within medical devices.

* A minimum 2 year of Regulatory Affairs or Quality experience required.

* RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.

* General understanding of product development process and design control.

* Thorough understanding of FDA, Europe and international medical device regulations.

* Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

* Ability to analyze and resolve non-routine regulatory issues using independent judgment.

Know someone at Stryker?

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