Director, Regulatory Affairs

Stryker Corporation Fremont , CA 94537

Posted 3 months ago

Job Description:

WHAT YOU WILL DO:

This critical role with Stryker's growing Neurovascular Division oversees and directs all regulatory activities for new and mature high risk products in the Stroke space to ensure alignment and compliance with local and regional registration requirements as well as with company policies. Develops and implements strategies for timely submission and approval of pre-clinical submissions, applications for clinical trials, marketing applications, etc. Provides counsel to and manages the regulatory team. Ensures timely preparation of organized and scientifically valid applications. Provides expertise in translating regulatory requirements into practical, workable plans. Interacts with regulatory agencies. Collaborates with R&D, Clinical, PMO and Operations to drive submissions.

  • Review regulatory compliance requirements for changes affecting product submission and device manufacturing in global markets.

  • Implement regulatory system changes to support evolving regulations and international standards.

  • Provide a strategic direction and tactical focus to the Regulatory Affairs organization and influence the direction of divisional RA activities.

  • Ensure that pre-market submissions, product registrations, and related functions are conducted in compliance with international standards and government regulations in support of company mission.

  • 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 strategic nature.

WHAT YOU WILL NEED:

  • 10 years Regulatory Affairs medical industry experience, preferably with Class III Medical Devices.

  • Extensive understanding of FDA and global regulations.

  • Extensive background in the development of regulatory submissions and documentation.

  • Proficient knowledge of clinical trial strategy and study design with good working knowledge of statistical methods and data reporting.

  • Excellent grasp of change control and test/validation requirements.

  • Strong strategic, decisionmaking, and risk assessment abilities.

  • Highly developed written and oral communication, technical writing and editing skills.

  • Excellent organizational, leadership, interpersonal and influencing skills.

  • Comprehensive understanding of relevant medical procedures, practice, terminology, and products.

  • Thorough knowledge of product development process and design control.

  • Documented continuing education in regulatory affairs

WHO WE WANT:

  • Sets direction. An innovator who defines ways to create value and deliver on Stryker's mission and strategic imperatives.

  • Builds organizational capability. A strategic executive who continuously breaks down barriers, identifying new and more effective ways to accomplish tasks and goals.

  • Inspires others. A genuine, relationship-focused leader who connects, collaborates and fosters an inclusive environment of enthusiasm, trust and pride. He/she makes others want to follow, building momentum for action and positively influencing outcomes.

  • Champions talent development. A manager who focuses on maximizing the ability, potential and contributions of themselves and others. Fosters an environment where people can excel through developing, coaching and rewarding performance.

  • Delivers results. A driven player/coach who sets high goals for personal achievement and organizational success. He/she measures success against the best internal and external benchmarks.

Work From Home: Regularly scheduled days

Travel Percentage: 30%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.


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Director, Regulatory Affairs

Stryker Corporation