Regulatory Compliance Coordinator in San Jose, CA at Stryker Corporation

Date Posted: 2/12/2020

Job Snapshot

Job Description

Responsibilities:

  • Document, follow-up on, and close product complaints as reported from various sources
  • Work with engineering groups to ensure product investigation is complete and accurate
  • Review complaint records prior to closure to ensure records are compliant with all relevant regulatory requirements
  • Review complaints for potentially reportable adverse event status, including evaluation and follow-up regarding MDR/MDV reporting
  • Complete complaint investigations and MDR/MDV reports within internal and regulatory timelines
  • Work from verbal and/or written instructions
  • Knowledge of applicable international regulations and standards (QSR, MDD, ISO 13485, CMDCAS, etc.) and willingness to train others in quality assurance/GMP-related topics
  • Develop and maintain positive relationships with regulatory agencies through professional oral and written communications
  • Communicate directly with customers and regulatory agencies regarding reported complaints and resolutions
  • Work with other departments on known and emerging issues to make quality improvements
  • Document, follow-up on, and close product field actions as required

Mental Requirements and skills/experience:

  • Must be able to communicate effectively (verbal and written) with high customer service

  • Strong detail orientation and ability to meet deadlines.  Planning and organization skills a must

  • Ability to work in team environment, but also self-starter with ability to work independently

     Strong critical thinking and problem solving skills
  • Previous work experience in regulated industry preferred
  • Proficient in Microsoft Office (Word, Excel or Access, PowerPoint)

Education:

  • High school diploma required, Associate’s and/or Bachelor’s degree (B.S. or B.A.) preferred

Work From Home: Not available

Travel Percentage: 0%

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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