Senior Regulatory Affairs Specialist in Tempe, AZ at Stryker Corporation

Date Posted: 10/22/2018

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 Senior Regulatory Affairs Specialist develops strategies for worldwide governmental approvals to introduce new, modified and mature products to the market by preparing worldwide regulatory submissions and negotiates product approval.  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 life cycle 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 medical device 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. 

Preferred/Desired Qualifications

  • Awareness of international regulatory requirements and systems, including EU and Japan markets
  • Strong analytical skills required with the ability to analyze technical requirements and regulations which apply to the corporation
  • Proficient in timely review of technical and clinical data.
  • Ability to mentor, train and provide work direction
  • Additional computer skills: Adobe Acrobat and document processing/publishing tools

What you need

  • Bachelor’s degree preferred in life science, engineering discipline or similar field 
  • 3 - 5 years’ experience in regulatory areas.
  • Ability to travel up to 50%. (For remote candidates this entails going to Tempe site and for all candidates this includes a trip to EU or Japan at least once per year.)

Work From Home: Yes

Travel Percentage: Up to 50%

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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