Product Reviewer/Auditor Medical Devices – Sterilization
Bangalore, IN
4d ago

At UL, we know why we come to work.

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.

As our global footprint continues to spread across the world, we are looking for

Product Reviewer / Auditor Medical Devices Sterilization

Location : UL office in Warsaw, Równoległa 4 or home based

In this role, you will be a part of the UL Medical Regulatory Team. Working with limited supervision, you will independently assist and support processing of manufacturer submissions to the Medical Devices Directive, forthcoming Medical Device Regulation and where applicable, ISO13485.

What you’ll learn & achieve :

What you’ll learn & achieve :

  • Perform contract review / project planning for technical file / design dossier evaluations and quality management system audits
  • Assess technical file / design dossier and quality management systems against European Directives, essential requirements and latest common technical specifications
  • Act as subject matter expert for sterilization and biocompatibility
  • Support regular quality system and technical audits, including unannounced audits
  • Subject to training and qualification milestones, perform key CE certification decision making responsibilities to support safe products to market
  • Perform key development and support of UL’s processes for future Medical Device Regulations
  • Participate in development and delivery of training materials to UL assessors
  • Support EU Notified Bodies and Competent Authorities activities on as needed basis e.g. NB / CA audits of UL
  • Participate in the development of UL requirements and assessment methods. Integrate continuous improvement concepts into all aspects of the job
  • Provide guidance and support to customers as required. Participate in client training and customer forums
  • UK / Overseas travel is required.
  • What makes you a great fit :

    What makes you a great fit :

  • A relevant Degree in microbiology or related discipline
  • 5 years hands-on experience with the design development and sterilization of medical devices including in depth experience of gamma and ETO sterilization methods.
  • Experience in the design and manufacture of non-active devices
  • Extensive experience with MDD 93 / 42 / EEC, MDD 2007 / 47 / EC including MEDDEVS;
  • In depth knowledge of appropriate standards : ISO 10993 series of standards, ISO 13485, ISO 14971
  • Excellent verbal and written communication skills, ability to deal professionally with confrontation
  • Strong innovative and analytical skills
  • Fluent English language skills
  • Desirable : auditing experience, ideally taken Lead Assessor course.
  • What you’ll experience working at UL :

    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 : We offer an interesting job in an experienced, highly motivated international team. A full time stable job, life-insurance, private medical insurance, lunch card and training courses via UL University will round up our benefits.
  • 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 our company page and division page :

    Please add the following clause : I hereby give consent for my personal data included in my application to be processed for the purposes of the recruitment process under the Regulation (EU) 2016 / 679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95 / 46 / EC (General Data Protection Regulation) .

    Please be advised that the data administrator is UL International Polska Sp. z o.o. with headquarter in Sękocin Nowy, Al.

    Krakowska 81. The given personal data will be processed for the recruitment process being carried out. The obligation to provide them results from the provisions of the Act of June 26, 1974.

    Labor Code (consolidated text from 1998 No. 21, item 94, as amended).

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