Post Market Regulatory Specialist in Tempe, AZ at Stryker Corporation

Date Posted: 11/4/2020

Job Snapshot

Job Description

Stryker is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives. We are currently seeking a Post Market Regulatory Specialist to join Stryker’s Sustainability Solutions division based in Phoenix/Tempe, Arizona.

Who we want

  • Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations. 
  • Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.  
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 

What you will do

As a Post Market Regulatory Specialist, you are responsible for providing communications to physicians, sales representatives, health care professionals and other internal departments regarding product complaints. You determine reportability to the appropriate medical device authority for events that either contributed or could have contributed to adverse events. In addition, you will aid in developing applicable policies and procedures.

Additional responsibilities include:

  • Review reports of customer complaints and assess them for regulatory reporting
  • Interact with device related Agencies on vigilance reports and incidents
  • Prepare written customer communications by translating technical medical device complaint investigation reports into customer letters
  • Process Additional Information (AI) request letters from the FDA
  • Work and train other departments on their complaint handling responsibilities
  • Assist in completing product field action documentation
  • Maintain current on CHS TrackWise system and provide training as needed
  • Participate in all post-market surveillance activities as needed and facilitate Post Market Surveillance Meetings
  • Review and approve non-conformances and planned deviations
  • Aid in developing and executing process and product protocols and reports
  • Provide backup phone support to the complaint hotline
  • Partner with pre-market Regulatory personnel in developing post-market product requirements
  • Support field efforts and customer escalations and/or follow-ups

What you need

  • Bachelor’s degree required; Degree in engineering or scientific discipline preferred
  • Experience in medical device, biologics or pharmaceutical field preferred
  • Knowledge of international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.) preferred
  • Technical writing experience preferred

Work From Home: Occasional

Travel Percentage: 10%

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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