LHS Technical Consultant

Location US-TX-Austin
Job ID
2021-24527
# of Openings
1
Job Category
Engineering

 

AHL – Light Bulbs – Safer World

At UL, we know why we come to work.

Thousands of us around the world wake up every day with a common purpose to make the world a safer, more secure and sustainable place. Science is in our DNA; we are endlessly curious and passionate about seeking and speaking the truth. We take delight in knowing that our work makes a meaningful contribution to society, and we are proud that our culture is centered on integrity, collaboration, inclusion and excellence. UL stands at the forefront of technological advancement, and we are continually challenged to find new ways to foster innovation and positive change. Satisfying? Yes. Exciting? Absolutely!

What you’ll learn & achieve:

The Regulatory Affairs Consultant will work within Emergo’s consulting team, providing assistance with regulatory and compliance issues to clients in accordance with written Work Instructions and the signed proposal / SOW.

 

MAJOR DUTIES AND RESPONSIBILITIES:

(The duties and responsibilities used to describe the scope of the position are not necessarily limited to those outlined)

Provide Regulatory Affairs and/or  consulting services, independently or with oversight by a Senior QA/RA Consultant or Consultant Manager, which may include but are not limited to:

Provide Regulatory consulting services, such as:

  • Prepare/review regulatory submissions e.g., FDA 510(k), and compile/review technical files for compliance to applicable regulations
  • Handle client inquiries and provide support regarding medical device quality assurance and regulatory compliance issues
  • Perform research on regulatory issues and generate regulatory reports
  • Research and prepare regulatory classification and strategy reports
  • Review and identify gaps of technical documentation / regulatory submissions
  • Prepare premarket submissions to regulatory authorities
  • Perform literature searches and prepare Clinical Evaluation Reports
  • Assist in addressing and responding to deficiencies of product submissions identified by regulatory authorities
  • Guidance on testing requirements to support marketing submissions
  • Review and advise on labeling and marketing materials, including written documents and website

Support senior consultants and clients with Quality consulting services, such as:

  • Gap analysis of Quality Management System
  • Remediating non-compliant Quality Management System
  • Internal audits / Supplier audits
  • Maintenance and / or updating of Quality Management Systems

What makes you a great fit:

  • 3-5 years of Regulatory Affairs work experience
  • A demonstrated knowledge and understanding of medical device regulations 
  • Auditing experience an advantage (QSR, ISO 13485, MDSAP)
  • Experience with technical documents
  • Clinical Evaluation report preparation a plus
  • Client facing experience and strong interpersonal skills
  • Fluency in English, additional languages a plus

What you’ll experience working at UL:

  • Mission For UL, corporate and social responsibility isn’t new. Making the world a safer, more secure and sustainable place has been our business model for the last 127 years and is deeply engrained in everything we do.
  • People Ask any UL employee what they love most about working here, and you’ll almost always hear, “the people.” Going beyond what is possible is the standard at UL. We’re able to deliver the best because we employ the best.
  • Interesting work Every day is different for us here as we eagerly anticipate the next innovation that our customer s create. We’re inspired to take on the challenge that will transform how people live, work and play. And as a global company, in many roles, you will get international experience working with colleagues around the world.
  • Grow & Achieve We learn, work and grow together with targeted development, reward and recognition programs as well as our very own UL University that offers extensive training programs for employees at all stages, including a technical training track for applicable roles.
  • Total Rewards Total Rewards All employees at UL are eligible for bonus compensation. UL offers a generous 401k matching structure of up to 5% of eligible pay. Additionally, we invest an additional 4% into your retirement saving fund after your first year of continuous employment. We provide Healthcare Reimbursement Accounts and Health Savings Accounts that UL contributes to twice per year! Depending on your role, you can work with your manager on flexible working arrangements. We also provide employees with paid time off including vacation, holiday, sick and volunteer time off.

Learn More:

Working at UL is an exciting journey that twists and turns daily. We thrive in the twists and revel in the turns. This is our every day. This is our normal.

Curious? To learn more about us and the work we do, visit UL.com

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If you wish to request reasonable accommodation at any time, please email our Talent Acquisition team at Talent.Acquisition@ul.com.

UL is an Equal Opportunity Employer: Female/Minority/disability/Protected Veteran/Sexual Orientation/Gender Identity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. If you'd like more information about your EEO rights as an applicant under the law, please review the EEO is the Law and EEO is the Law Supplement.

Please review the following additional documents:

UL EEO Policy

Pay Transparency Statement

E-Verify Poster (English)

Right to Work Poster (English)