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Senior Regulatory Affairs Specialist

Company: LGC Limited
Location: Middleton
Posted on: April 10, 2021

Job Description:

LGC, Biosearch Technologies is looking for a detail-oriented and highly analytical Senior Reglatory Affairs Specialist to join its global quality team. The Senior Regulatory Affairs Specialist will be responsible for the development, preparation, execution and approval of regulatory submissions, including CE-IVD and US EUA, required to market new or modified in vitro diagnostic devices (IVD), reagents, instruments or research use only (RUO) products globally. This individual requires in-depth knowledge of national and international standards, and in coordination with management of Quality and Regulatory Affairs, this role will develop regulatory strategy, execute regulatory plans, and perform other activities that lead to approval and maintain regulatory compliance for LGC products. PRIMARY DUTIES AND RESPONSIBILITIES:

  • Comply with the Company's quality management system and global regulatory standards, especially complaint handling requirements.
  • Ensure accurate review of customer feedback, completeness and accuracy of adverse event or vigilance reporting to competent authorities when applicable.
  • Negotiate and establish product submission priorities that are aligned with region/country need and the annual strategic plans; identify and assess business risks for a given regulatory strategy.
  • Manage and coordinate technical file development to ensure reliable CE-IVD source documents for product registrations.
  • Support product registrations in assigned regions; monitor and track progress.
  • Develop and maintain procedures and/or work instructions for product registrations.
  • Interface with partners and customers to collect specific registration information.
  • Represent RA in platform core team meetings.
  • Interface with applicable regulatory agencies and international consulates.
  • Submit and maintain registrations for all instruments.
  • Prepare Technical files and Documentation to support product launches.
  • Plan, evaluate and improve the efficiency of business processes and procedures to enhance speed, quality and output.
  • Analyze and resolve non-routine regulatory issues and complex problems using independent judgement.
  • Serve as a resource to the product development, marketing, and sales teams in reviewing and approving marketing material, including user's manuals, product brochures, customer communication, and instructions for use or labeling as required.
  • Monitor and report on regulatory developments, approvals and trends; May develop and mentor others within RA or other cross-functional departments.
  • Understand and comply with ethical, legal, and regulatory requirements applicable to our business.
  • Other duties as assigned to support QA/RA and Business goals. WORK ENVIRONMENT: Working conditions are normal for an office environment. This role routinely uses standard office equipment. This is a full-time, regular position, with 40 hours regularly expected per workweek. The hours of work and days are Monday through Friday, 8 a.m. to 5 p.m. However, the position may require occasional evening and/or weekend work. The position does require occasional weekend and/or evening work and an ability to travel up 20% of time, dependent on regulatory activities. Travel out of the area typically involves overnight stays. Experience required
    • Minimum 7 years' experience in the device/diagnostic, biologic and/or pharmaceutical industry, with a minimum of 3 years in the area of regulatory affairs. Education, experience and technical skills
      • Bachelor's Degree required, preferably in the biological sciences, chemistry or related science.
      • Demonstrated ability to interpret new regulations, and understand and interpret international regulatory requirements for in vitro diagnostic device (IVD).
      • Current knowledge of ISO 13485, ISO 14971, Quality System Regulations (QSR), European quality system standards and Clinical Laboratory Improvement Amendments (CLIA) law and regulations.
      • Regulatory Affairs Certification (RAC) preferred.
      • Excellent communication skills, both written and verbally, including proven technical writing skills and compiling successful submissions. Essential competencies and behaviors:
        • Experience authoring and submitting medical device registrations/licenses/submissions applicable to regional area.
        • Experience reviewing product labeling and advertising/promotional material.
        • Clinical or statistical experience preferred.
        • Proficiency with Microsoft Office, Adobe software; working knowledge of EtQ Reliance and IFS highly desirable.
        • Experience supporting change control and new product development projects.
        • Understanding of genomics and molecular biology products preferred.
        • Ability to work autonomously cooperatively in a complex and rapidly growing company.
        • Develop and mentor others within RA or other cross-functional departments, promoting open communication and feedback.
        • Proven ability to prioritize changing objectives to meet business needs.
        • Results-oriented, ensuring targets are met on time and on budget. Physical demands are normal for an office environment.--

Keywords: LGC Limited, Madison , Senior Regulatory Affairs Specialist, Other , Middleton, Wisconsin

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