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Vice President, Regulatory Affairs and Quality Assurance

Job Summary:

The Vice President of Regulatory Affairs & Quality Assurance has overall responsibility for leading all aspects of regulatory and quality strategy development and implementation and for communicating directly with global regulatory agencies (U.S. FDA, Health Canada, EU, ISO, Japan MHW, etc.) on all regulatory matters. Responsible for company’s product quality and reliability to meet or exceed customer expectations. This position will either be based out of the Seattle headquarters or our Redwood City, CA office (w/expectation of being in Seattle frequently). 

Essential Functions:

  • Representing the Regulatory and Quality functions, serve as a key and active member of the Senior Operational team, interacting with the team to ensure business objectives are aligned and that the company is performing to operational objectives.
  • Coach and mentor the Regulatory and Quality organization ensuring appropriate levels of accountability for decision making and clearly communicate cross functionally within the organization.
  • Promote the development of a facility-wide understanding of the key elements related to quality systems and regulatory compliance requirements.
  • Effectively lead and manage Regulatory and Quality staff including direct mentoring and leadership of managers in each organization.
  • Provide sound advice and guidance regarding the impact of regulatory and quality issues on overall corporate strategy and operations.
  • Serve as the Quality Management Representative and primary point of contact with the Company’s Notified Bodies and external auditors. Ensure the company is in full compliance with regulatory agencies
  • Develop and execute efficient and effective regulatory strategies to bring products to market (domestic and international).
  • Develop and implement strategies for educating the FDA on various aspects of the technology and scientific principles upon which the product system operates.
  • Maintain excellent relationships with regulatory agencies, subcontractors, and providers of non-clinical and clinical studies
  • Effectively Manage the preparation and submission of marketing approval applications (510(k)s, PMAs, CE Product Certifications, Design Dossiers, International Licenses, etc.)
  • Oversee and assist in the review and approvals of product packaging and labeling and Sales and Marketing promotional materials.
  • Identify relevant quality standards for product development and manufacturing and partner effectively with Product Development in defining design requirements for domestic and international markets.
  • Ensure Quality compliance with regulatory agencies and all applicable standards Worldwide
  • Develop and execute quality design and quality assurance strategy for new product development and sustaining business activities.
  • Effectively create and support process enhancement initiatives to maintain an environment of continuous improvement throughout the organization.
  • Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate.
  • In support of the quality system, provide effective leadership support, training and guidance to all company personnel.

Requirements:

  • At least 10 years of experience in clinical in vitro diagnostic regulations, including successful pre-market submissions for domestic and international markets. Experience with molecular diagnostic and companion diagnostics a plus.
  • Minimum of BS degree in scientific discipline, preferably life sciences, biomedical, or other engineering science. MS or PhD a plus; regulatory certification (RAC) and auditor (CQA) qualifications a plus.
  • Progressive & proven record of leadership and managing regulatory/quality organization’s with global responsibility and establishing long term strategic growth initiatives.
  • Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization.
  • Extensive experience in cGMP and other Regulatory compliance requirements. Experienced in regulatory filings for US (510(k), IDE and PMA) and other key countries/regions.
  • Authoritative knowledge of current US and international in vitro clinical diagnostic regulations and guidelines.
  • Demonstrated success in the development and implementation of facility quality management systems, and assuring compliance to all applicable regulations.
  • Ability to think ‘out of the box’ and create novel solutions to challenging problems.
  • Work well in team settings and also be able to work independently to ensure completion of time critical projects.
  • High level of personal and professional integrity and trustworthiness with strong work ethic and the ability to work independently with minimal direction.
  • Proven ability to develop and manage high performing teams focused on accountability and meeting and exceeding expectations.
  • Ability to lead, influence, create and work within cross-functional team environments.
  • Previous management and  team leadership experience
  • Excellent communications and presentation skills.
  • Excellent interpersonal and strong leadership skills; self-motivated and flexible to changing schedules.
  • Strong attention to detail, good oral and written communication skills
  • Ability to travel domestically and internationally approximately 20% of the time.

Other:

  • See benefits at NanoString
  • NanoString is an EOE
  • NanoString participates in E-Verify. E-Verify is a web-based system that allows an employer to determine an employee's eligibility to work in the US using information reported on an employee's Form I-9. The E-Verify system confirms eligibility with both the Social Security Administration (SSA) and Department of Homeland Security (DHS). For more information, please go to the USCIS E-Verify website.

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