Director of Quality Assurance / Regulatory Affairs

Company: Applied BioCode

Position: Director of Quality Assurance / Regulatory Affairs

Location: Santa Fe Springs

Posted: February 3, 2022




Create and execute quality strategies and plans for the QMS, ranging for simple to high complexity.

Provide a high level of expertise and experience to the Team, while serving as a project member or team member.  Holds signature responsibility for designated areas.

Represent the company in interaction and negotiations with regulatory agencies regarding quality requirements and strategies. Organizes and manages meetings with regulators, including agendas and training/preparation of company personnel attending the meeting.

Leads the quality strategy for the company globally.

Leads the ISO 9001.13485 based quality programs globally to ensure effective implementation of quality systems, continuous improvement efforts, and promotion of a quality/compliance culture.

Provides leadership in product quality problem solving resolution efforts across the organization.

Act as the primary authority for compliance actions such as product or service corrective actions or recalls.

Serve as chair of the Quality Management Team meeting to facilitate review and decision making based on the operation of quality systems and quality metrics.

As needed, provide leadership on quality and regulatory affairs matters during mergers and acquisitions.

Liaise with peers in other operating companies to share experience and best practices.

Act as the primary authority for internal quality compliance matter.

Monitor FDA, EU and ISO laws and regulations, and provide their interpretation to company leadership. Provides comments to management for inclusion in responses to FDA and other agency legislation/regulatory/guidance.

Serve as team expert for material review board, product labeling as they relate to registration and commercialization of medical devises.

Suggest opportunities for improvement that have a significant impact (cost, cycle time, quality, etc.) and assists in developing or executing an implementation plan.

Perform other related duties and required and/or assigned.







Regulatory and Clinical Affairs Main Responsibilities

Responsible for development of regulatory strategy and representation of Regulatory Affairs R&D project teams.

Communicate regulatory strategy to the senior management and other relevant functions.

Lead to assure successful planning and completion of regulatory activities.

Lead to set up and manage interactions with clinical sites to assure successful Clinical Studies.

Act as the primary authority for liaison with customers and regulatory authorities regarding quality matters, including hosting inspections and responding to observations.

Familiarity with product development, manufacturing, and supply chain cycles.

Develop regulator strategies, policies, guidelines, programs, procedures and investigative approaches and metrics to track compliance.

Develop, negotiate, and execute regulatory strategies (especially for US FDA).

Represent company interests with national government agencies, industry associations and/or other organizations in all regions (31 countries) for the purpose of ensuring compliance with legislation, regulations, and/or guidelines that impact the business in the clinical diagnostic market.

Design and implement appropriate metric to track performance and apply counter measures  diagnostic tools to close any gap.

Establish and meet requirements for clinical diagnostic capability (CE, IVD, FDA, 510k etc.) in all functions including design, manufacturing, and service, and take on any other tasks as required.

Responsible for of global regulatory submissions as well as directing communications and interaction with US FDA and other regulatory agencies worldwide.

Responsible for product registration with regulatory agencies.

Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.