8 days old

Analyst II, Regulatory Affairs

Chaska, MN 55318
  • The Analyst II, Regulatory Affairs coordinates, facilitates, and reports on post-market regulatory programs for design change, adverse events, vigilance and recall reporting.
  • Ensures timely preparation of organized and scientifically valid reports both internally and externally
  • Coordinates and manages the post-market regulatory reporting and compliance activities in accordance with company procedures and regulatory requirements.
  • Creates, monitors and controls regulatory project schedules related to postmarket activities
  • Key accountability is to maintain global regulatory compliance programs for product corrective action, adverse event reporting, vigilance requirements, stop ship in Oracle, and supporting global registration processes.
  • Coordination of on-going regulatory activities with Corporate Quality and Regulatory Affairs and coordinating and communicating with domestic and international business partners and direct interaction with regulatory agencies on postmarket product issues and questions
  • Exercise judgment within defined procedures and practices to determine appropriate action and influence teams and functions on requirements for maintaining compliance.
  • May develop and track project plans.
  • Monitors policies procedures and standards relating to Regulatory Affairs, evaluates impact and communicates to interested parties.
  • Recommends changes to improve practices and procedures.
  • Utilize Danaher Business System (DBS) tools to drive compliance and effective processes; developing regulatory metrics and scorecards and institute data-based process improvements which will align with corporate and business unit goals.
  • Assure no significant interruptions to the business due to compliance issues
    • A Bachelor€™s degree with 2+ years of experience, Master€™s or Doctoral degree with 0+ years of experience. Preferably in areas of life sciences, engineering, or quality assurance. 
      • Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQE, CQA, RAC, Six Sigma, Lean Principles)

        Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The €œEEO is the Law€ poster is available here.","industry":"Medical Device


Posted: 2020-05-21 Expires: 2020-06-20

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Analyst II, Regulatory Affairs

Chaska, MN 55318

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