JOB DESCRIPTION
Summary: As a Global Market Access Expert, you will be responsible for developing and implementing strategies to obtain and maintain market access requirements and information. You will work closely with cross-functional teams to ensure compliance with international regulatory requirements and facilitate the entry of our products into diverse markets.
RESPONSIBILITIES
- Lead regulatory requirements strategies for medical devices in various countries and regions, provide guidance on compliance strategies.
- Collaborate with research and SME teams in order to conduct research, validate information and support the data injection in UL digital platforms.
- Liaise with international regulatory agencies, notified bodies, and testing laboratories to obtain info related to approval process and resolve any ambiguity that may arise.
- Monitor changes in global regulatory requirements and assess the impact on existing and future certifications/processes.
- Provide regulatory support for product lifecycle management, including post-market surveillance and reporting.
- Develop and maintain relationships with key stakeholders, including national authorities and customers, to ensure successful market access and compliance.
- Train and mentor on regulatory requirements and best practices for global market access.
- Participate in industry associations and regulatory forums to stay abreast of trends and developments in medical device regulations.
QUALIFICATIONS
- Bachelor's degree in a scientific field preferred.
- Minimum of 5 years of experience in regulatory affairs or a related field within the medical device industry, with a focus on international markets.
- Proven track record of successful medical device requirements knowledge and approvals in multiple countries.
- Excellent communication and interpersonal skills, with the ability to work effectively in a multicultural environment.
- Detail-oriented with strong analytical and problem-solving skills.
- Ability to manage multiple projects simultaneously and meet deadlines.
- Additional language skills are a plus.
What the Team is Saying
What We Do
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. Our science is your advantage.
Why Work With Us
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.
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Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Depending on the role we offer hybrid or remote opportunities.
