Product Reviewer/Auditor - Medical Devices (Location is flexible based on business needs)

Job content

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! UL is a global independent safety science company with more than a century of expertise innovating safety solutions from the public adoption of electricity to new breakthroughs in areas such as sustainability, renewable energy, mobile payment security and nanotechnology. Dedicated to promoting safe living and working environments, UL helps safeguard people, products and places in important ways, facilitates trade and provides peace of mind. Our 1,000+ Standards of Safety serve as the bedrock of compliance for nearly 200 different industries. The UL mark is accepted worldwide and our reputation for public safety and helping manufacturers around the globe build safer products is unmatched. More than 14,000 employees together with representatives and business partners serve customers locally in over 100 different countries. To build up our Regulatory Medical business in Europe we are looking for a Senior Project Engineer. What you’ll learn & achieve: Medical Devices are some of the most regulated products in the world. 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 Device Directive 93/42/EEC and the Medical Device Regulation 2017/745, ISO13485 and MDSAP. Within the framework of our highly regulated Notified Body you will:

• Perform contract review / project planning for technical file and quality management system audits.
• Assess technical file and quality management systems against European Directive 93/42/EEC and 2017/745, essential requirements standards and MEDDEV requirements
• Support regular quality system and technical audits, including unannounced audits.
• Subject to training and qualification milestones, perform key CE conformity assessment activities to support safe products to market.
• Perform development and support of UL’s Conformity Assessment processes for CE certifications;
• Support Competent Authority activities on as needed basis e.g. Competent Authority 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 (25-50%). What makes you a great fit:
• Successful completion of a university or a technical college degree or equivalent qualification in relevant studies, e.g. Medicine, Pharmacy, Engineering or other relevant sciences;
• 4+ years’ professional experience in the field of healthcare products or related activities, such as in manufacturing, auditing or research, of which two years shall be in the design, manufacture, testing or use of the device or technology to be assessed or related to the scientific aspects to be assessed;
• Experienced with standards such as IEC 60601 series of standards, biocompatibility, ISO 10993 standard, software IEC 62304 for the products you have work with is essential;
• Experience of risk management whether compiling the RM file or participating in the RM process according to ISO 14971 standard is required;
• Experience working under an ISO 13485 quality system is advantageous;
• Knowledge and experience of conformity assessment procedures. Desirable
• Auditing experience is ideal but not essential;
• Fluent English language skills essential and other EU language skills desirable not essential;
• Process orientated to deliver business success;
• Excellent verbal and written communication skills;
• Confident, calm and decisive personality;
• Strong innovative and analytical skills;
• Ability to deal professionally with confrontation. 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 126 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:
• Competitive remuneration package with yearly bonus
• Friendly environment and collaborative colleagues
• Casual dress code
• Training and Development (provided by UL University) 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 UL is an Equal Opportunity Employer and we welcome applications from all sections of the community. Our Talent Acquisition team can provide further information and support reasonable adjustments that a person may require during the interview process. You can read more about our commitment to supporting a diverse and inclusive environment here: https://www.ul.com/about/diversity or contact our Talent Acquisition team regarding specific needs here: recruitmenteurope@ul.com