Vice President of Regulatory Affairs

4 weeks ago

Carlsbad, United States SOLVD Health Full time

Job Description Summary

The Vice President of Regulatory Affairs is responsible for overseeing the development and execution of the Company's Quality, Clinical and Regulatory strategies for our innovative products and related services across domestic and international markets. The role provides expertise and guidance in interpreting government regulations, agency guidelines, and internal policies to assure compliance with standards.


Required Education and Experience

  • Bachelor's degree (B.A/B.S.) in related field, advanced degree strongly preferred.
  • 15 plus years related experience or equivalent in medical diagnostic/device or life science industry.
  • 5 plus years' experience in a senior management role in a commercial stage company with global operations.
  • Demonstrated experience interacting with the Food and Drug Administration (FDA) required, experience with other regulatory agencies preferred.


Essential Functions

  • Oversees the Clinical, Quality and Regulatory departments and may represent the Company externally in discussions with regulatory authorities worldwide with emphasis on US and Canada. 
  • Provides efficient and effective Regulatory representation across the organization and interact with the Food and Drug Administration (FDA) and other regulatory agencies.
  • Directs and implements advancement of FDA Quality System Regulations (FDA QSR) and also supports ISO 13485 program to ensure the integrity, confidentiality and availability of information.
  • Manages Corrective and Preventive Action (CAPA). Collaborates with other associates to ensure corrective and preventive activities are effective and are managed and processed in accordance with requirements.
  • Creates regulatory strategies, systems and processes to ensure that development, registration and commercialization plans meet all federal, foreign, and company requirements to enable the effective advancement of products from design concept through marketing and post market surveillance.
  • Oversees the design, implementation and conduct of innovative clinical trials.
  • Identifies and develops strong collaborative relationships with study investigators, clinical sites and external service providers.
  • Directs the assessment and improvement of key business processes to ensure compliance with current and future regulations set forth by the US FDA and equivalent international bodies.
  • Maintains accountability for all relevant timelines and deliverables.
  • Leads clinical team to secure global regulatory approvals for pipeline products.
  • Provides strategic consultation and guidance to external and internal subject matter experts with regard to go/no-go development decision criteria on significant clinical components and implications.
  • Oversees implementation of safety strategy across studies, including regular review of safety data (including but not limited to SAEs) and response to safety issues.
  • Manages timely reporting of clinical trial issues to regulatory authorities and the generation of clinical study reports.
  • Participates in defining and developing broad strategies consistent with business objectives and clinical and regulatory requirements.
  • Ensures that New Product Development teams have appropriate clinical and regulatory representation for all key development programs.
  • Supports the development of strategic and tactical plans for all regulatory and clinical submissions including all US and OUS filings, ensures completeness, administrative and scientific accuracy; facilitates timely government approvals for marketing new and modified products.
  • Provides leadership to a team of Clinical Training Coordinators (CTCs), participating in development, performance appraisal, merit recommendation, and promotion of staff.
  • Represents company by acting as a liaison between external collaborators and internal stakeholders.
  • Leads all regulatory audit, compliance and corrective action processes.
  • Partners with Quality, R&D, Legal, Operations, and other appropriate department leaders in overseeing entire product realization efforts to ensure integrity and quality of data.
  • Provides insight into the potential regulatory risks and benefits of business plans, including directing alternative action plans based on risk/benefit analyses.
  • Participates as a member of the leadership team in defining the strategy, direction and vision of the organization.

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