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Senior Specialist, Regulatory Compliance in Fremont, CA at Stryker Corporation

Date Posted: 12/7/2018

Job Snapshot

Job Description

At Stryker Neurovascular, our mission centers on Complete Stroke Care which aims to reverse the trend of 120,000 – a staggering 1 in 20 – US deaths caused by over nearly 800,000 US strokes per year. We are the market leader in cutting edge, less invasive neuro-technologies that not only improved patient outcomes, but also led to double digit divisional and Stryker’s overall business growth.

If you’re a results-driven Regulatory professional looking to make a difference in the world, consider why Stryker may be right for you.

Who we want

We are seeking energetic, results-driven regulatory professional for exciting, high impact opportunity to work on projects that make a difference in the world.

Results Driven: Thrives on accomplishing tasks and constantly driven to do more.

Strategic: Creates alternative ways to proceed. Faced with any given scenario, can quickly spot the relevant patterns and issues.

Focus: Takes direction, follows through, and makes the corrections necessary to stay on track. Prioritizes then acts.

Collaborators: Collaborates and builds relationships with internal and external stakeholders.

Communicators: Articulates well and expresses ideas effectively.

Learners: Great desire to learn and looks to continuously improve.

Teammates: Supports, encourages, and inspires others.

What you will do

We are looking for a collaborative team player who is interested in the European Medical Device Regulation (EU MDR) implementation, standards management, participating in global agency audits and supporting regulatory process improvement initiatives. Operating in a fast-paced environment, the Regulatory Compliance, Senior Specialist will liaise with internal and external customers and establish strong relationships with regulatory agencies and notified bodies. You will be asked to work cross-functionally to develop regulatory compliance strategies, new processes and provide regulatory audit support.

What you need

  • 2 + years of Regulatory Affairs, Regulatory Compliance and/or Quality Assurance medical industry experience
  • Internal and external audit experience
  • Product field action regulatory assessments
  • Thorough understanding of FDA, European and international medical device regulations.
  • General understanding of product development process and design control.
  • Effective research and analytical skills.
  • Ability to manage multiple projects.
  • Effective written and oral communication, technical writing and editing skills.
  • Ability to work independently with minimal supervision.

Work From Home: No

Travel Percentage: Up to 25%

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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