Oxford Immunotec, Inc.

U.S. Laboratory Regulatory Manager

Job Location US-MA-Marlborough | US-MA-Norwood
Posted Date 2 weeks ago(2/12/2018 9:47 AM)
ID
2018-1866
# of Openings
1
Department
Legal

Overview

 

The interpretation and application of regulations and standards governing U.S. clinical laboratories are essential functions of this role. The U.S. Laboratory Regulatory Manager is responsible for overseeing and managing the Company's compliance with regulatory frameworks applicable to U.S. clinical laboratory operations. This position is expected to remain abreast of applicable regulations, monitor the regulatory landscape for emerging trends and communicate trends that may impact Company policies and procedures. The incumbent will be a part of the Regulatory Affairs & Quality Assurance Leadership Team and will be expected to further the company regulatory and quality function through proactive participation in and contributions to this team and the broader company goals. While the primary focus of the role is on US laboratory regulations, there will be scope for broader regulatory activities and objectives related to US FDA regulations and international registrations.

Responsibilities

  • Provide regulatory guidance to departments and development project teams concerning evaluation, implementation and promotion of clinical laboratory testing services and laboratory developed tests.
  • Review U.S. documents and materials, including U.S. promotional material, for compliance with applicable regulatory requirements, including consistency with applicable labeling or validation records for Company products or testing services mentioned in the materials.
  • Ensure appropriate CLIA certifications, CAP accreditations and out of state licenses are in place for our US laboratories. Prepare submissions and applications to facilitate timely approval or issuance of these or other associated accreditations as necessary.
  • Oversee or participate in the development, revision and implementation of policies and procedures needed to ensure laboratory regulatory compliance.
  • Design and deliver laboratory regulatory training to enhance Company awareness of applicable regulations and requirements.
  • Provide advice on necessary validation requirements and pragmatic interpretation of such requirements based on regulations and guidance.
  • Ensure issues and/or concerns relating to laboratory regulatory matters are identified, investigated, and optimally resolved to support the Company's laboratory business needs.
  • Serve as a regulatory resource for the Clinical Affairs and Medical Affairs departments in relation to the development and oversight of relevant clinical study protocols and investigator initiated studies.
  • Monitor Company compliance with regulations through audit participation.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Communicate updates to regulations and accreditation standards to the appropriate functional groups.
  • Provide additional regulatory support to our kit / product regulatory team to facilitate registration of kit products in the US and/or international markets; to review US promotional materials and other US regulatory activities relating to FDA regulations, requirements and guidance.
  • Participate proactively in the RA/QA Leadership Team.

Qualifications

  • BA, BS, BSc (or equivalent), preferably in the natural sciences; at least 7-10 years of experience in the medical device and/or diagnostic industry-several years of experience specifically in the U.S. laboratory regulatory field
  • In depth knowledge of CLIA regulations, CAP accreditation standards and other U.S. local, state and federal regulations and standards governing U.S. clinical laboratories and laboratory developed tests
  • Understanding of the scientific, technical and regulatory issues involved in validating and implementing test methods
  • Ability to set priorities and adapt to changing Company needs and manage multiple projects within established time frames
  • Ability to clearly and effectively communicate complex issues and concepts orally and in writing.
  • Ability to effectively and confidentially advise and interact with executives, department directors and managers, staff, and external organizations and agencies
  • Ability to design, develop, and direct initiatives related to regulatory requirements in a pragmatic and understandable way, and to promote a quality culture
  • Ability to work independently and on projects with a team and filling various roles such as team member, facilitator, or leader

 

PHYSICAL DEMANDS:  

The physical demands described within the Position Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile.  The employee is also required to interact with a computer, and communicate with peers and co-workers. Minimal travel required including international travel.  Job requires employee to walk considerable distances in the facility during the course of his or her work.

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