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Senior Quality Assurance / Regulatory Affairs Consultant

Company: UL
Location: Cambridge
Posted on: May 16, 2022

Job Description:

Senior Quality Assurance / Regulatory Affairs Consultant Location GB-Cambridge Job ID 2020-21059 # of Openings 1 Job Category Engineering 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! Within our Life & Health Sciences division, we work every day to not only protect life, but also protect hope. We enable people around the world to access the most advanced care to treat themselves and their loved ones. We help our clients understand the specific needs of different patient groups and design and implement products that will work to ensure safety in healthcare. (link: https://www.ul.com/healthcare-and-life-sciences )

In this role, you will join Emergo by UL. Emergo is a leading global consulting company within UL specializing in global medical device and IVD compliance. To grow our international team (we have a presence in 20+ countries), we are looking for a Senior Regulatory Affairs Consultant who can be a Subject Matter Expert for our global clients! What you'll learn & achieve: As a Quality Assurance Consultant, you will be regularly called upon to act as a regulatory Medical Device and IVD Subject Matter Expert, providing our clients with consulting support for their Regulatory and Quality needs related to compliance with the applicable regulations and standards:

  • Assisting manufacturers and their suppliers in developing, implementing and maintaining quality system compliance programs and procedures.
  • Performing onsite and remote quality system assessments and audits for compliance with the FDA QSRs, ISO 13485:2016, MDSAP, MDR and other specific country regulations.
  • Conducting 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.
  • Writing white papers.
  • Regulatory Pathways (product classification assistance and requirements to bring product to market) for major global markets.
  • Pre-Submission and clinical strategy support, as well as clinical evaluationsCompilation of technical documentation to submit to local authorities in accordance with the requirements for Europe, US and other global markets; gap assessments of existing client documentation. What makes you a great fit:
    • You have an academic background in a scientific field (e.g. Biochemistry, Biological Engineering, Chemistry or similar)
    • A minimum of 8 years of -Quality Assurance work experience in the medical device or diagnostics field.
    • A demonstrated and 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.
    • Experience with In-Vitro Diagnostic or software products considered an advantage
    • RAC, CQE, CQA (or other quality certification) a plus.
    • Extensive hands on experience writing and reviewing technical regulatory or clinical reports documents.
    • Client-facing experience and strong interpersonal skills with the ability to work with all levels of a client's organization. What you'll experience working at UL:
      • Mission: Shape the way we approach and deliver our solutions to promote a secure and more sustainable world
      • People: Work with colleagues, who listen to, learn from and challenge each other so that you can continually push for excellence and results
      • Interesting work: Your work at UL will challenge you to try fresh approaches, work autonomously, drive change and help you gain in-depth experience in your field
      • Grow & achieve: Growth and development are part of our DNA. Grow & achieve with targeted development, reward and recognition programs as well as your very own UL University
      • #ThisIsOurNormal: Competitive renumeration & bonus packages, possibility to work remotely, and much more! Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.

Keywords: UL, Cambridge , Senior Quality Assurance / Regulatory Affairs Consultant, Professions , Cambridge, Massachusetts

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