Senior Manager Regulatory Affairs (NIPT)

United States of America, California, San Jose

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The Senior Manager Regulatory Affairs (NIPT) will be responsible for:

  • Participates in establishing and implementing regulatory policies and procedures that affects own area(s).
  • Provides regulatory guidance associated with the development, support, and manufacturing of the Company’s
  • medical device products.
  • Primarily responsible for the development and implementation of Regulatory strategies and plans to support the
  • timely introduction of new products and the preparation and review of government submissions to achieve timely
  • and cost effective clearance/approval. Fully accountable for managing the information provided for maintaining
  • registrations and listings.
  • Reviews and approves product labeling to ensure conformance with Regulatory requirements and/or approved
  • product claims.
  • Primary regulatory contact with affiliates to achieve registration.
  • Partners with QC/QA and manufacturing as a participant in the change control processes and associated
  • validations and re-validations.
  • Works on complex issues; develops solutions.
  • Position has HR responsiblity for direct and indirect reports which includes hiring/firing decisions, interviewing,
  • selection, performance feedback, discipline, pay decisions and handling employee grievances/complaints.
  • Directs the maintenance of product and process regulatory compliance.

Minimum Qualifications:

  • Bachelor’s Degree or equivalent, Master's Degree/PhD preferred
  • 9 years regulatory affairs experience in the medical product industry

Travel Requirements:

  • 25% based on business needs

Roche is an equal opportunity employer.

Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs