Senior Regulatory Affairs Specialist
Company: LGC Limited
Posted on: April 10, 2021
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
- 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
- Manage and coordinate technical file development to ensure
reliable CE-IVD source documents for product registrations.
- Support product registrations in assigned regions; monitor and
- Develop and maintain procedures and/or work instructions for
- Interface with partners and customers to collect specific
- Represent RA in platform core team meetings.
- Interface with applicable regulatory agencies and international
- Submit and maintain registrations for all instruments.
- Prepare Technical files and Documentation to support product
- 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
- Monitor and report on regulatory developments, approvals and
trends; May develop and mentor others within RA or other
- 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
- 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
- Experience reviewing product labeling and
- 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
- Understanding of genomics and molecular biology products
- 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
- Results-oriented, ensuring targets are met on time and on
budget. Physical demands are normal for an office
Keywords: LGC Limited, Madison , Senior Regulatory Affairs Specialist, Other , Middleton, Wisconsin
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