Senior Regulatory Compliance Specialist - 20937BR - EN in San Jose, CA at Stryker Corporation

Date Posted: 4/6/2018

Job Snapshot

Job Description

Position Responsibilities.
  • Responsible for developing, applying, and revising procedures to maintain and improve quality compliance and standards as well as reviewing and approving concessions, non-conforming product and corrective actions as denoted by applicable regulations and procedures
  • Use understanding of industry practice and company policies to effectively implement and improve product quality and the quality management system
  • Responsible for completing and approving investigations, and, determining reportability to the appropriate regulatory agencies for events that either contributed or could have contributed to adverse events
  • Review and approve investigations of returned products and/or related reports
  • Review reports of customer complaints and assess them for regulatory reporting
  • Submit initial and follow-up reports to device related regulatory agencies as appropriate
  • Interact with regulatory agencies on adverse event reporting and vigilance reports
  • Review and approve non-conformances and planned deviations
  • Review and analyze data for trending purposes
  • May coordinate recalls and complete associated documentation
  • Recommend corrective and/or preventive actions to address non-conformities and deviations
  • Work with engineering groups to ensure testing as required on product investigations is completed
  • Interact with customers and sales force to solve reliability issues and/or complaint issues.
  • Work from verbal and/or written instructions.
  • Aid in developing and executing process and product protocols and reports
  • Aid in developing statistical process controls and analyzing data
  • Act independently to determine daily activities and project implementation
  • Provide leadership, training and mentorship to team members
  • May review and approve non-conformances and planned deviations
  • May aid in developing and executing process and product protocols and reports
  • May aid in developing statistical process controls and analyzing data
  • May participate in internal and external audits

Job Requirements

  • Bachelor’s or Master’s degree in engineering, life sciences or nursing (mechanical, electrical, industrial, software, biomedical, computer, biology, physics, chemistry, etc.) preferred.
  • 3+ years experience in medical device with Bachelor's degree; 1 year of experience with Master's degree.
  • Regulatory Affairs Certification preferred.
  • Must be able to analyze and resolve non-routine product issues using independent judgment with the assistance of engineering support when required
  • Working knowledge of data collection, data analysis, evaluation, and scientific method.
  • Engineering schematics/drawing/prints reading and interpretation
  • Commitment to excellence and high standards
  • Excellent organizational, problem-solving, and analytical skills to lead to sound, timely decisions
  • Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
  • Ability to interface with both technical and non-technical personnel at all organizational levels.
  • Proficient with Microsoft Office and ability to learn corporate systems.
  • Ability to understand and explain detailed regulatory compliance programs and/or issues.
  • Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
  • Ability to analyze and resolve non-routine regulatory issues using independent judgment.
  • Must be able to observe and correct minute inconsistencies (e.g. in the written word, form usage, etc.).
  • Self-motivated.
  • Previous experience in legal, technical or medically related area preferred.
  • Knowledge of applicable international regulations and standards (CFR, MDD, QSR, ISO 13485, CMDCAS, etc.).

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