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Director of Regulatory Affairs and Quality
Ref No.: 18-29299
Location: Waltham, Massachusetts
Responsibilities:
  • Leads the strategy for new In-Vitro Diagnostics (IVD) to the regulatory agencies working with CDx pharma partners. For CDx or Lifecycle Support areas have responsibility for creation and submissions of US FDA pre-submissions, 510(k)s and PMAs for assigned projects.
  • Specifically, for Companion Diagnostics, bridges requirements between Drug and IVD regulatory affairs and development teams.
  • Establish validation policies and procedures in accordance to GMP regulations and industry standards.
  • Develop Standard Operational Procedures (SOP), validation plans and procedures to improve the validation process and validation training program. Ensures proper execution of validation plans.
  • Liaison for Company as the Management Representative before regulatory authorities providing counsel, training, and interpretation of FDA and other regulatory issues to company personnel
  • Contributes to the development and realization of business by development of adequate regulatory strategies.
  • Provides regulatory guidance and support to product development teams including R&D, engineering and involved personnel across applicable legal entities.
  • Establish SOP to achieve efficiency within regulatory affairs, including the interfacing with other departments.
  • Provide input to the management team in establishing short and long-term business strategic plans and objectives and direct implementation of business strategic plans to achieve objectives.
  • Responsible for keeping management team informed of regulatory status of products and significant regulatory issues.
  • Responsible for the preparation and conduct of all inspections by any regulatory authority.
  • Review and ensure that the company's SOPs are in accordance with GCP and GLP guidelines.
  • Responsible for Company's Quality Compliance to ensure compliance with regulatory agencies and all applicable standards
  • Responsible for ensuring Company's compliance with Quality System procedures and company policies
  • Responsible for Company's Quality Assurance to ensure product quality and reliability to meet or exceed customer expectations and to make quality competitive advantage
  • As the Company's Management Representative, responsible for ensuring processes necessary for the quality management system are established, implemented and maintained, reporting to executive management on the performance of the quality management system and any needs for improvement and ensuring the promotion of awareness of regulatory and customer requirements throughout the organization
  • Responsible for facilitating adequate review and approval of promotional, advertising, and labeling items
  • This position is responsible for the development and leadership of strategies to mitigate risk to the business associated with vendors, suppliers, and other key constituencies.
  • Maintain awareness of new regulations and develop plan to insure compliance with the regulations.
  • Work with operations to ensure product specifications meet regulatory requirements.
  • Review annual Quality and Regulatory Affairs budgets looking for ways to optimize cost effectiveness.
  • Oversee quality aspects of the Clinical Laboratory Improvement Amendments (CLIA) laboratory.
Authorities:
  • Has the authority to take every necessary action to ensure that the requirements of all applicable regulatory standards are met.
Executive:
  • This position is responsible for leading the Quality and Regulatory Affairs department.
  • This position is expected to participate in the Executive Team contributing to the development and evaluation of business strategies.
  • Participation in regular Executive Team meetings.

Qualifications
Education and Experience:
  • Minimum four-year degree in a science discipline, business management, or quality sciences.
  • At least 5 years of experience with development of biomarkers and IVD companion diagnostics devices is required.
  • Minimum of 15 years progressive experience in Regulatory Affairs, Clinical Affairs and Quality Assurance.
  • RAC certification preferred.
  • ASQ CQM certification preferred.
  • Experienced in cGMP, ISO 13485, ISO 14971 and other regulatory compliance requirements.
  • In-depth understanding and experience with FDA and Client regulatory requirements relative to developing strategic regulatory development plans, and preparation, filing and managing of 510(k) / PMA submissions and Technical Files for Client marking.
  • Experience and ability to execute regulatory plans for US, Canada and Europe regulatory filings for US (51O(k), PMA, IDE) and other country submissions.
  • Outstanding administrative capabilities to build, motivate and manage a strong quality organization.
  • Excellent communication skills, both verbal and written, and the ability to interface effectively with engineering, manufacturing, sales and marketing, and administration.
  • A mature thinking and acting executive with good common sense and judgment, and a broad business perspective with Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.