Vice President, Quality Assurance and Regulatory Affairs

Location
Burlingame, California, United States
Posted
Oct 13, 2020
Ref
4168983003
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SUMMARY OF ROLE:

The Vice President, Quality Assurance and Regulatory Affairs (VP QA/RA) will report to the CEO and will be responsible for the management and continuous improvement of the quality assurance and regulatory affairs functions for all Inflammatix locations and products. The VP QA/RA will (1) maintain all aspects of the Quality Management System other than design controls; (2) establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in a GxP international regulatory environment, and (3) serve as the in-house subject matter expert and external-facing person on regulatory affairs responsible for driving regulatory communications, submissions, and inspections for successful commercialization of products in target markets worldwide.

PRIMARY RESPONSIBILITIES:
  • Continuously review and improve programs, policies, and practices to ensure FDA QSR, ISO 13485, and GxP compliance
  • Direct development and implementation of quality systems to ensure product reliability, efficacy, and compliance
  • Drive regulatory strategy, communications, submissions, and manage inspections to enable successful commercialization of products and manufacturing licensing
  • Collaborate with internal team members to address requests from regulatory agencies in a timely manner; assume primary responsibility for the creation of reports and documentation
  • Provide GxP Quality Assurance oversight of vendors and maintain quality agreements
  • Address and resolve nonconformances, deviation, and product complaints
  • Ensure organizational work processes conform with standard operating procedures
  • Oversee implementation of eQMS and other related systems
  • Oversee compliance auditing program to fulfill regulatory requirements
  • Actively scan regulatory landscape for changes that impact the company's policies and products
  • Produce and manage QA/RA plans and budgets
  • Serve as SME on product development teams and post-market surveillance teams
  • Grow strong and diverse QA and RA teams
  • Lead a quality culture within the organization

QUALIFICATIONS:
  • Bachelor's degree or higher, with a focus in engineering, life sciences, or similar
  • 10+ years of relevant experience in industry, of which at least 5 is in medical devices
  • 5+ years in a leadership QA/RA position

KNOWLEDGE, SKILLS, AND ABILITIES:
  • Able to lead and manage regulatory submissions and inspections in major global markets
  • Excellent working knowledge of FDA QSR and ISO 13485 requirements
  • Extremely detail-oriented
  • Collegial and effective in working across departments

COMPENSATION AND CLASSIFICATION:
  • Classification: Full-time position based in Burlingame, California
  • Compensation: Competitive and commensurate with experience; includes equity package
  • Benefits: Medical, dental, and vision; 401(k), competitive package and perks