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Principal Post Market MDR Specialist in Redmond, WA at Stryker Corporation

Date Posted: 5/13/2019

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 Principal Post Market MDR Specialist to join our Medical Division to be located in Redmond, WA.

Who we want

  • Business-oriented evaluators. People who effectively interpret information to demonstrate the effects of business initiatives, regulation and industry trends for sales, management and leadership teams. 
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 
  • Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues. 
  • 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 Principal Post Market MDR Specialist, you will be responsible for determining reportability to the appropriate medical device authority for events that either contributed or could have contributed to adverse events.

  • Responsible for reviewing and approving investigations and closure of product inquiries.
  • Responsible for reviewing and approving of team members reportability decisions.
  • Responsible for drafting and submitting medical device reports.
  • Function in a leadership role to support the Customer Quality QRA specialist team.
  • Review and approve investigations; will be assigned more complex investigations.
  • Review reports of customer complaints and assess them for regulatory reporting (US <30 days, International agencies as appropriate to the regulations); will be assigned more complex complaints.
  • Lead all necessary reporting activities related to the complaint handling process.
  • Drive reportability recommendations for QRA Specialists.
  • Interact with device related Agencies on vigilance reports and incidents globally.
  • Train/mentor new and existing Customer Quality team members.
  • Identifies and implements improvements for the Customer Quality Team.
  • Provide input on internal system and methods to maintain regulatory compliance and support post-market surveillance.
  • Participate in the CAPA process as a representative from the Post Market Surveillance and MDR/Vigilance Specialist teams.

What you need

  • A minimum of a Bachelor’s Degree (B.S. or B.A) is required.
  • A minimum of 7 years of experience in post market medical device complaint handling required.
  • Good analytical skills.
  • Good communication skills; oral and written.
  • High level of computer proficiency.

Preferred Qualifications:

  • Knowledge of defibrillator products
  • Knowledge of 21 CFR Part 820, Quality System Regulations
  • Knowledge of 21 CFR Part 803, Medical Device Reporting
  • Knowledge of 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA Statute
  • Knowledge of the Medical Device Directive (MDD)
  • Knowledge of Canadian Medical Device Regulation (CMDR)

Work From Home: No

Travel Percentage: None

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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