UL, LLC Senior Regulatory Affairs Consultant - Medical Devices/ IVD in Des Moines, Iowa
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 Senior Consultant at Emergo by UL is regularly called upon to act as a regulatory Medical Device and IVD Subject Matter Expert, providing clients with consulting support for their regulatory and quality needs related to compliance with the applicable regulations and standards. Working as either part of a global team, a regional group, or solo, the consultant will perform work independently as a client-facing contributor or as a team lead, in accordance with written Work Instructions and the stated scope of work; and within agreed upon timeframes established with clients.
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 support which may include:
+ + Research and advise on device classification and regulatory pathways and strategies for various markets
Prepare and submit regulatory premarket submissions, such as 510(k), EU technical documentation file,s Canada MDL, other regulatory submissions as applicable.
Assist in addressing and responding to deficiencies of product submissions identified by regulatory authorities
Prepare meeting requests (e.g., Pre-Sub), and facilitate those meetings (either by teleconference or face-to-face), between clients and the FDA or other regulatory agencies
Interact and negotiate directly with regulatory authorities on behalf of clients
Assist clients with other regulatory concerns, such as labeling, risk assessment, design change evaluation, etc.
Review documentation and advise clients in developing more effective documentation, e.g., labeling, test reports, in conjunction with relevant standards, regulations, guidance documents, and current regulatory policies.
Assist and mentor junior level consultants, as needed
Clinical Evaluation support and reports
Conduct in depth training programs and public/ client sessions on quality and regulatory related topics, which showcase the individual's position as a subject matter expert
Standards and awareness training
The consultant may also be expected to provide some quality assurance support which could include:
- Performing quality system assessments and audits for compliance with the FDA QSRs, ISO 13485:2016, MDSAP, MDR and other specific country regulations.
Implementation and support of client Quality Management Systems
As an internal SME, participation in the following:
- Developing and maintaining internal Emergo programs and processes for and within the global consulting group
Develop and present trainings to colleagues regarding regulations and procedures
Provide guidance to Business Development in determining appropriate scope and budget of proposals, including scoping calls with clients.
Review Marketing materials for accuracy, including written documents and website content
What makes you a great fit:
College degree or equivalent
8 years of work experience in the medical device or diagnostics field
Extensive hands on experience writing and reviewing technical regulatory or clinical documents
Experience with In-Vitro Diagnostic or software products considered an advantage
RAC, CQE, CQA (or other quality certification) a plus
A thorough knowledge and understanding of medical device quality system requirements (such as, FDA QSR, ISO 13485, MDR/IVDR, MDSAP) based on professional and industry experience
Client-facing experience and strong interpersonal skills with the ability to work with all levels of a client’s organization
Highly productive, with a bias for action
Business 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 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.
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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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 theEEO is the Law (https://ul.icims.com/icims2/servlet/icims2?module=AppInert&action=download&id=353634&hashed=-442359237) andEEO is the Law Supplement (https://ul.icims.com/icims2/servlet/icims2?module=AppInert&action=download&id=353633&hashed=2016765212) .
Please review the following additional documents:
UL EEO Policy (https://ul.icims.com/icims2/servlet/icims2?module=AppInert&action=download&id=353638&hashed=-1688922441)
Pay Transparency Statement
E-Verify Poster (English) (https://ul.icims.com/icims2/servlet/icims2?module=AppInert&action=download&id=353635&hashed=1393483610)
Right to Work Poster (English)
UL is committed to hiring and retaining a qualified diverse workforce. We are proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class U.S. Citizenship is required for most positions.
LocationTX-Austin | IL-Northbrook | NY-Albany | TX-Plano | DC-Washington, D.C. | IA-Des Moines | MI-Royal Oak | FL-Gainesville | Las Vegas
Job ID 2021-22330
of Openings 1
Job Category Engineering
- UL, LLC Jobs