Job Description

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 an Associate International Regulatory Manager to join our Endoscopy division to be based in San Jose, CA 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.

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

* Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.

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

* Insightful advisors. Managers who lead strategy development and provide guidance to teams

What you will do

As the Associate International Regulatory Manager, you will be responsible for providing leadership, organization and coordination of the Endoscopy Divisions global regulatory strategy and submission processes. You will also be responsible to direct and supervise activities of Regulatory Affairs staff, developing key talent on a global stage. You will partner closely with Stryker personnel worldwide to prioritize submissions, fulfill requests from global regulatory agencies and navigate an ever-changing global regulatory landscape to help improve Endoscopys global footprint.

* Lead employees engaged in international regulatory activities including liaising with pre market product development teams for registration strategy/execution, supporting international affiliates with re-registrations, tenders, and general requests/issues.

* Lead projects and processes to implement or improve systems across the business.

* Lead the International Regulatory function for the Division including people management. Execute global regulatory strategy to support Strykers global business goals.

* Interact with international Stryker affiliates (regulatory, marketing, commercial) and design division functions for global registration planning, resource allocation, and conflict resolution.

* Interact with corporate RAQA function to collaborate and coordinate international efforts.

* 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.

* Serve as Subject Matter Expert for regulatory processes.

* 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.

* Manage and provide updates for regulatory metrics. Implement appropriate enhancements.

* 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 on-board top talent.

* 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.

* Full management of a team, including management of people, defining roles and responsibilities, planning for the department's future needs and operations, counselling employees on performance and contributing to employee pay decisions or changes.

What you need

* A minimum of a Bachelors degree (B.S. or B.A.) required; preferably in engineering or life sciences.

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

* A minimum of 7 years of experience in an FDA regulated industry required; preferably with medical devices.

* A minimum of 3 years of Medical Device Quality or Regulatory Affairs experience required.

* Experience interacting with regulatory agencies preferred.

* Thorough understanding of FDA and/or international medical device regulations required.

* Strong interpersonal, written and oral communication skills.

* Strong technical knowledge of medical device products.

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

* Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and International requirements.

* Demonstrate technical knowledge of medical device product lines.

* 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

* Demonstrated process or people management leadership skills.

* Experience with recruiting and people development preferred.

LI-Remote