Job Description
UL Solutions was recently designated as an Approved Body for active Medical Devices - to continue our success journey, we are looking for a new colleague to join our team in the United Kingdom (Basingstoke, Warrington or remote) as a
Technical Lead Medical Devices. You will be playing a key role in driving the regulatory program forward, ensuring technical partnership working with other notified bodies and fellow experts. You will be leading the regulatory work for UK approved bodies.
Responsibilities
- Support of UL Solutions UK Approved Body including code authorisations, contract review and certificate decision making functions.
- Report to the CMIT regulatory leadership of the Business Unit and support a sustainable and regulatory compliant growth in-line with business target.
- Support of commercial lead and opportunity development, as well as onboarding of customers.
- Manage and provide technical liaison between UL and partner organisations, including EU NBs.
- Leverage opportunities on partners that allows UL business to succeed whilst meeting regulatory obligations.
- Support hiring, training and development of Medical Device related expertise that aligns with and support UL stakeholders (e.g: audit programs, MHRA, EU authorities) and partners expectations
- Support and lead development of procedures, processes, tools and trainings.
- Develop KPIs and lead improvement initiatives.
Qualifications
- A university or a technical college degree or equivalent qualification in relevant studies, e.g. medicine, pharmacy, engineering, other relevant sciences or Regulatory
- Strong background in Medical Device Regulatory processes, namely UK’s MDR 2002 (as amended), EU’s MDR 2017/745 (or MDD possible), and, optionally, US 510(k) approval process
- Detailed knowledge of conformity assessments under the UK MDR 2002 as amended
- At least four years' professional experience in the field of healthcare products or related activities, such as in quality, regulatory, manufacturing, auditing or research
- Experience in Medical Device Single Audit Program, ISO 13485 and knowledge of UK’s MDR 2002 (as amended) and EU’s MDR 2017/745 is desirable
- Experience in the area of quality management
- Strong communication skills with focus on connectivity, decisiveness and customer centricity
- Ability to work in a global matrix organisation
We offer
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 130 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. 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. We also believe our people are our foundation so we provide training and development to foster career development.
About Us
A global leader in applied safety science, UL Solutions transforms safety, security, and sustainability challenges into opportunities for customers in more than 100 countries. UL Solutions delivers testing, inspection and certification services, together with software products and advisory offerings, that support our customers’ product innovation and business growth.
The UL Certification Marks serve as a recognized symbol of trust in our customers’ products and reflect an unwavering commitment to advancing our safety mission.
We help our customers innovate, launch new products and services, navigate global markets and complex supply chains, and grow sustainably and responsibly into the future.
From the adoption of electrification to the enablement of 5G and new mobility, we collectively look toward new frontiers, working for a safer world. Our science is your advantage.
Mission: Working for a safer world
About The Team
Consumer, Medical & Information Technologies (CMIT) business provides certification, testing, inspection, verification, consulting and training services related to traditional consumer electronics products and the latest categories of products (such as wearable devices and networked cars), small household appliances and medical devices. We can provide comprehensive and applicable safety and regulatory requirements support for innovative products and technologies, provide pre conformance testing at the design and development stage to identify potential compliance problems, and formulate targeted testing plans for all target markets. UL Solutions' CMIT business has helped many manufacturers improve product safety, comply with regulations and industry requirements, bring innovative technologies and electronic products to the market, and meet consumers' requirements for product reliability and performance.
