Senior Regulatory Affairs Specialist in San Jose, CA at Stryker Corporation

Date Posted: 7/31/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    San Jose, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    7/31/2018
  • Job ID:
    R401390

Job Description

Who we want


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

Achievers. Thrives on accomplishing tasks and constantly driven to do more.

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


The Regulatory Pre-Market team develops and executes global regulatory strategy for new and/or modified medical devices to gain approvals for clinical investigations and commercial distribution.  This critical function advises project and/or product development teams on, and to ensure compliance with, applicable global regulatory requirements .  Additionally, the Sr. Regulatory Affairs Specialist is responsible for preparing complex regulatory submissions and/or presentations (i.e. pre-submissions, IDEs, 510(k)s, Technical Files, etc.) to regulatory bodies (i.e. FDA, Notified Bodies, etc.) and for any related communications.


•Partner regularly with marketing, engineering, clinical and quality on project and product development teams •Investigate and evaluate regulatory background of products and medical procedures to assess regulatory implications•Develop global regulatory strategy for products

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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