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

We are currently seeking a Senior Manager, Regulatory Affairs to join our Medical division to be based in Redmond, WA or remotely anywhere in the United States.

Who we want

* Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.

* Accuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting.

* Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.

* Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.

* Compliance-focused orchestrators. Managers who carefully oversee people, processes, and deliverables to ensure compliance with company policies and procedures

* Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.

What you will do

As the Senior Manager, Regulatory Affairs, you will be responsible for providing leadership, organization and coordination of the Medical Divisions global regulatory strategies and submissions to support high impact product launches and ongoing market access. You will confidently and collaboratively work across the RA team and cross-functional partners as well as with individuals across international locations and time zones, cultures and languages to support International Division sales growth. In addition, you will lead the team to drive global standards within product design and provide regulatory guidance on international markets.

* Assesses links between global, societal, and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy.

* Leads advocacy activities of a more advanced and global strategic nature.

* Develops and updates global, regional and multi-country regulatory strategy, and aligns regulatory strategies to organizational strategies.

* Provides guidance to integrate regulatory considerations into global product entry and exit strategy.

* Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes.

* Assesses all requirements and potential obstacles for market access and distribution.

* Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations.

* Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions.

* Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.

* Develops and manages programs that train stakeholders on current and new regulatory. requirements to ensure organization-wide compliance.

* Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions.

* Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases.

* Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.

* Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions.

* Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process.

* Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees.

* Manage day-to-day regulatory processes to ensure issues are appropriately evaluated

* Establish annual budgets and quarterly forecasts. Make necessary changes with appropriate management involvement.

* Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met

* Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations.

* Establish standard process to ensure appropriate resolution and management of the responsible task owner.

* Chair meetings required to drive closure of regulatory issues.

* Represent regulatory processes during internal and external audits.

* Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets.

* Recruit, select and develop talent within team to increase performance. Actively address performance issues on team

* Maintain a high level of team engagement.

* Participate in advocacy activities of a more advanced technical and/or tactical or strategic nature.

What you need

* A minimum of a bachelors degree (B.S. or B.A.) required; preferably in Science or Engineering.

* A minimum of 10 years of experience within a regulated industry required; preferably in Medical Device.

* A minimum of 5 years of experience within regulatory affairs required.

* A Masters Degree or advance degree preferred.

* A RAC Certification preferred.

* Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements required (IDE, PMA HDE, 510(k) and EU Design Dossiers).

* Demonstrated technical knowledge of medical device product lines required.

* Demonstrated written, verbal, listening, communication, and team-building skills.

* Demonstrated ability to collaborate effectively with and lead cross-functional teams.

* Demonstrated ability to effectively prioritize and manage multiple project workloads.

* Demonstrated experience with trending and analysis reporting preferred.

* Demonstrated process improvement and management skills.

* Experience with recruiting employees preferred.

* Experience in managing a team of direct reports including people development required.

* Progressive management experience required.

* Comprehensive understanding of relevant medical procedures, practices, terminology, and products.

* Thorough knowledge of product development process and design control.

LI-Remote

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