Regulatory Affairs Consultant

Location US-TX-Austin
Job ID
2022-27760
# of Openings
1
Job Category
Advisory / Consultancy

 

LHS

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!

 

Every day, our consultants help both small and global businesses ensure their medical devices meet all the necessary regulatory standards to enter and stay on the market. What’s exciting about that is that our team members have the opportunity to work with any number of devices types and with clients all around the world at the same time. Not only does this foster more diverse and experienced consultants, it helps ensure variety in the work you do. UL is more than a consulting firm; we foster an environment of learning, collaboration, and excitement. Working with UL, you have the advantage of always being able to push yourself to new levels of growth and success while helping products reach users and patients, all in the knowledge that we advance safety science and improve the quality of people’s lives. For those who desire to make a difference every single day, UL offers the ideal space. Here, your career truly changes lives. For anyone who is excited about building a well-rounded career and helping clients grow their business, Emergo by UL offers a truly unique experience.

What you’ll learn & achieve:

The Quality and Regulatory Affairs Consultant will work within Emergo’s regulatory affairs team and support Emergo’s global consulting services, providing assistance with regulatory and compliance issues. May also be called upon to liaise with local consulting partners and regulatory authorities in smaller markets where needed.

 

JOB RESPONSIBILITIES:

  • Assist consulting team and clients with the preparation and submission of medical device registration/licensing applications to a single or specific number of regulatory markets.
  • Prepare renewals or amendments to the above, and act as support to a project team lead (project manager or consultant); this may include direct client interaction which should be well documented.
  • Develop and leverage knowledge of requirements and expectations for medical device submissions, understand the registration process, including whether tasks should be completed in parallel or sequentially and clearly delineate each process/phase to clients.
  • Assist with client documentation review, gap analysis, provide input regarding the acceptability of existing data, and explain how to satisfy the submission requirements.
  • Assist with or redirect internal or external inquiries related to quoting project hours and scope, including potential grouping or classification as applicable .
  • Escalate complex regulatory issues identified by team or clients to senior experts as appropriate and follow through to resolution. Prepare regulatory reports. Perform activities such as:
  • Research on regulatory issues, involving web searches, review of internal library and other means
  • Summarizing technical and regulatory information in a written form
  • Serve as Lead Consultant on multi-market research projects as needed

Handle client inquiries and provide consultation regarding medical device quality assurance and regulatory compliance issues, such as:

  • Drafting / reviewing mandatory or operating procedures needed for quality assurance or regulatory compliance
  • Reviewing product labeling
  • Responses to issues arising from registrar or regulatory inspections / audits
  • Act as regulatory support on larger consulting project teams comprised of multiple stakeholders, including senior consultants, business development and project management
  • Where appropriate, act as initial liaison with local regulatory authorities on behalf of clients
  • Support Consulting team with RA and QA priorities as needed
  • Read and follow the Underwriters Laboratories Code of Conduct, and follow all physical and digital security practices

What makes you a great fit:

  • Bachelor’s degree, preferably in a Medical, Engineering or Science field
  • Advanced, professional-level written and verbal English and excellent communication skills
  • Generally 2-5 years of Quality Assurance and/or Regulatory Affairs experience working in the medical device field, in a regulatory, submissions or quality support role. Consulting experience a plus
  • Excellent attention to detail, research or device registrations experience a plus.
  • Proficiency with Microsoft Office software.
  • Strong multitasking, organization and prioritization skills.

UL has COVID-19 protocols and policies in place to ensure the safety of our employees, customers and clients. Effective November 1, 2021, the company mandates that employees are vaccinated against COVID-19 as a condition of employment (except where prohibited by law), subject to reasonable accommodation as required by law.

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 125 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 customers 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: 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.

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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)