Senior Manager, Quality And Regulatory Affairs

Cepheid Vista , CA 92083

Posted 5 months ago

This is a management position based in Vista, CA with responsibility for driving regulatory and quality activities for Leica's cancer diagnostic/pathology imaging business. Will provide leadership to the Imaging Solutions business via continuous improvement of quality and regulatory systems to ensure customer's expectations for compliance, reliability and national & international standards are met. Provides leadership and direction through managers and senior professional staff. Responsible for growth and development of all QRA associates. Accountable for the performance of the organization including on-time-delivery and effectiveness of registrations/submissions and compliance of quality system(s).

Major Responsibilities

  • Leadership of the Imaging Solutions QRA team at the Vista, CA and Dublin, Ireland sites.

  • Serve as a member of the Imaging Solutions leadership team.

  • Develop strategies and plans for regulatory clearance/approval of imaging technologies intended for cancer diagnostics in the anatomic pathology market. Lead negotiations with the US FDA through the pre-submission and 510(k) or PMA process. In conjunction with global regulatory experts, develop strategies for approvals in desired markets (e.g. EU, China, etc.)

  • Manage, coordinate and represent the Imaging Solutions business in GMP and other quality system audits. Strive for strong audit outcomes and zero audit findings.

  • Maintain and drive CAPAs as needed to address Quality and Regulatory gaps.

  • Maintain and report metrics for PPM and Customer Complaints, ensuring customer quality focus for on-market products.

  • Maintain and drive site-specific compliance trainings on monthly basis and drive quarterly Quality Management Reviews with the site Leadership team.

  • Accountable for the performance and results of the QRA organization, including: quality system compliance and effectiveness, regulatory strategies and submissions, relationships with regulators, and effective partnership across Leica departments and sites.

  • Develops strategies and plans to meet performance objectives of the organization. Effectively delegates initiatives and tasks.

  • Lead and develop the Imaging Systems QRA team according to the Danaher Leadership Anchors (e.g. Charts the Course, Builds Teams, Drives Innovation, Acts with Integrity). Responsible for developing associates through continuous development planning (D4G); drive successful and measurable employee engagement.

  • Manage timelines, budgets and resource allocation according to requirements of the business.

  • Effectively use Danaher Business System (DBS) tools to drive continuous improvement.

Required Skills/Experience

  • Bachelor's degree in engineering, science, medical, or technical field and 8 years' experience with increasing responsibility in medical device QA/RA, or

  • Graduate degree in engineering, science, medical, or technical field and 5 years' experience with increasing responsibility in medical device QA/RA.

  • Graduate-level education (M.S., Ph.D) in bioengineering highly preferred.

  • Must have regulatory affairs experience in medical imaging modalities, preferably pathology imaging or other In Vitro Diagnostic (IVD) imaging.

  • Related experience includes 5 years managing people

  • Must have experience managing medical device quality systems in compliance with US FDA regulations (21 CFR) and ISO 13485.

Required Competencies

  • Proven track-record of leading successful regulatory clearances/approvals for medical imaging devices or applications.

  • Proven regulatory affairs leadership; RAC certification highly desirable

  • Exceptional communication skills (verbal/written/presentation/relationship building) with ability to work collaboratively with customers, cross-functional project teams and regulators.

  • Organized and detail-oriented

  • High level of initiative, self-motivation and energy.

  • Reliable and responsive.

  • Customer focused

  • High level of integrity

Travel % of Travel, include approximate overnight stays per week

  • Travel expectations for this role is low (15-25%)

Location:

  • This role is based at the Vista, California office.

Diversity & Inclusion

At Danaher, we are dedicated to building and sustaining a truly diverse and inclusive culture. These are not just words on a page

Diversity and Inclusion is a top priority for the company, and it ties deeply to each of our core values. Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate 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.


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Senior Manager, Quality And Regulatory Affairs

Cepheid