Staff Specialist Regulatory Affairs in Tempe, AZ at Stryker Corporation

Date Posted: 10/9/2018

Job Snapshot

Job Description

Who we want

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.

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 Affairs team supports new product development for both domestic and international market releases and provides regulatory oversight post market.  They participate on cross functional teams to develop global regulatory strategies, author regulatory submissions, interact with regulatory agencies/notified bodies and review labeling and marketing material during the pre-market phases.  The Regulatory Affairs team also evaluates proposed design changes for both new products and sustaining products. They support the product lifecycle through obsolescence by assessing changes made to the device post launch to determine the regulatory impact to the current clearance/approval by all regulatory bodies. 

  • Exposure to all types of single-use Class I and II products with an array of clinical applications.
  • Partner regularly with the engineers on the team compiling regulatory submissions.
  • Provide strategic direction on how to best streamline our process and use more of a risk-based approach to making decisions.
  • Learn about innovative reprocessing methods, testing and criteria.   

What you need

  • A Bachelor’s degree required, life science or engineering discipline is preferred.
  • 5-7 years’ experience in regulatory areas.
  • Extensive experience in highly-regulated industry, preferably with FDA regulations and compliance.
  • Regulatory experience in class II medical devices preferred.
  • Expertise with 510(k) submissions preferred.
  • Ability to manage the regulatory functions, as well as involvement in key projects.
  • Ability to interface with both technical and non-technical personnel.
  • Ability to work effectively in a team environment with shifting priorities and timeliness requirements
  • Possesses excellent interpersonal, analytic, and problem-solving skills.
  • Travel 10%

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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