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Job Title: Regulatory Reporting Specialist

Company Name: Stryker Orthopaedics
Location: Mahwah, NJ
Profession: QA/QC and Auditing

Job Description:

Lead divisional efforts to evaluate potential non-conforming product and drive organizational decision on product field actions. Communicate recall information both within the organization and externally to FDA, and end customers. Drive closure and final disposition of recalls.


ESSENTIAL DUTIES AND RESPONSIBILITIES:


  • Initiate Product Field Action Summary documents in document control system and assign to manufacturing location for substantial completion.

  • Communicate potential actions to internal stakeholders.

  • Receive partially completed Product Field Action Summary documents from manufacturing location and coordinate action decision at divisional level. Complete Product Field Action documents. Manage approval process for rapid decision making and action.

  • Communicate recalls to FDA within 10 days of decision.

  • Draft recall communication to field and coordinate any other communication that Marketing may want to make in conjunction with field actions.

  • Submit recall communication to FDA District office and receive approvals.

  • Manage and oversee recall communications with FDA including any additional information FDA requests in classification letters or closure letters.

  • Oversee reporting of recall effectivity to corporate entities.

  • Drive timely recall closure by coordinating resources and product disposition in conjunction with management.

  • Track metrics on process timeliness and effectiveness.

  • Participate in process improvement and automation.

    • QUALIFICATIONS:


  • 3+ years experience as a Regulatory or Quality professional in a regulated manufacturing environment. Prefer experience with recalls and non-conforming product disposition.

  • Demonstrated applied knowledge of FDA and international medical device regulations.

  • Demonstrated ability to effectively work cross functionally with other departments including Operations, Product Development and Marketing.

  • Demonstrated problem-solving and troubleshooting skills.

  • Demonstrated oral and written communication skills a must.

  • Demonstrated ability to exhibit a positive, energetic approach to teamwork.

  • Knowledge of manufacturing processes and demonstrated ability to advocate product excellence and quality.

  • Demonstrate results orientation, ability to multi-task, and ability to learn quickly.

  • Demonstrated ability to respond to the urgent needs of the team, with proven track record of meeting deadlines.

  • Prefer computer proficiency with MS Office suite including MS Visio and MS-Project.

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