Regulatory Affairs Consultant - Emergo by UL

Location US-TX-Austin
Job ID
2021-26072
# of Openings
1
Job Category
Engineering

 

LHS – Medical Devices – 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:

Regulatory Affairs - Leverage extensive medical device industry/consulting experience to provide expert level regulatory consulting services:  

  • Develop effective product registration strategies for customers (product classification and solutions for bringing product to the market)
  • Use medical device background knowledge to perform critical review and gap analysis of product documentation and regulatory submissions
  • Prepare high-quality premarket submissions, e.g., FDA 510(k) / de novo, Canadian MDLs, EU Technical Documentation Files, and other global registrations
  • Request and support Pre-Submission meetings and liaise with government authorities on behalf of client.
  • Assist in addressing and responding to deficiencies of product submissions identified by regulatory authorities
  • Provide SME guidance in all aspects of global Medical Device and In Vitro Diagnostic (IVD) regulations
  • Develop Clinical Evaluation / Performance Evaluation Plans & Reports
  • Support with strategy and submissions for novel devices/technology: FDA Breakthrough Device Designation / de novo submissions; Health Canada guidance communications; other international markets as needed.
  • Specialized support in areas such as SaMD, cybersecurity, risk management, sterilization, etc.
  • Use industry experience to guide and assist manufacturers with meeting Post-Market requirements, e.g., change management and promotional compliance

Quality Assurance - Perform Quality Management (QMS) assessments and audits for compliance with the FDA QSR, ISO 13485, MDSAP, EU MDR, IVDD/IVDR and other country-specific regulations for medical device manufacturers worldwide. 

Develop and deliver standard or customized training modules to clients on quality and regulatory-related topics 

Provide additional Quality Consulting services such as: 

  • Preparing & assisting manufacturers with external audits(e.g., ISO registrar, FDA, Notified Body); attending audits to act as subject matter expert where called upon.
  • Conducting internal / supplier audits (as a lead auditor)
  • Gap analysis and remediation of QMS for a diverse number of manufacturers with a wide array of medical products
  • Supporting with maintenance and/or updating client compliance to additional requirements (e.g., MDSAP, EU MDR/IVDR)
  • Review and assess compliance during acquisition due diligence activities; perform due diligence audits as requested

Strategic, Training and Support - Customize consulting solutions to clients’ specific needs, both on-site and off-site

Perform Lead Consultant role in multi-faceted projects; provide guidance and feedback to other team members during the project.

  • Perform peer reviews of colleagues’ work output to ensure high-quality, consistent deliverables
  • Join and support Sales in client calls to demonstrate Emergo’s expertise
  • Provide Emergo management and colleagues with updates regarding changes to global regulations and policies as well as feedback from clients / regulatory authorities
  • Effectively manage workflow to meet business goals and objectives. Provide regular reports to management regarding individual capacity, forecasting and other business metrics.
  • Coordinate with other UL offices on global service requests. Collaborate in scoping out work and developing proposals and statements of work to meet customer needs.
  • Participate in developing and maintaining internal Emergo procedures and QMS
  • Respond to internal requests for advice and guide others as an SME
  • Review and advise on labeling and marketing content
  • Develop and present trainings to colleagues regarding regulations and procedures to ensure a continued state-of-the-art knowledge base.

What makes you a great fit:

  • Bacherlor’s degree or equivalent in a scientific discipline, particularly biomedical engineering, quality engineering, microbiology or chemistry
  • ≥8 years of Regulatory Affairs and Quality Assurance Medical Device industry experience, ideally at a TeaBachelom Leader/Managerial / Director level
  • A demonstrated knowledge and understanding of global medical device regulations, especially MDSAP countries and the EU / UK
  • RAC, CQE, CQA or other quality certification preferred
  • Auditing experience to medical device standards (QSR, ISO 13485, MDSAP), a Lead Auditor Certification is an advantage
  • Experience with writing and compiling technical documentation
  • Client-facing experience and strong interpersonal skills with the ability to work with C level executives of a client’s organization
  • Fluency in Business-level English
  •  
  • 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.

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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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

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