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.

Key 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 or engineering discipline; an advanced degree is 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.

UL LLC has been and will continue to be an equal opportunity employer. To assure full implementation of this equal employment policy, we will take steps to assure that:

Persons are recruited, hired, assigned and promoted without regard to race, color, age, sex or gender, sexual orientation, gender identity, gender expression, transgender status, religion, creed, national origin, ethnicity, citizenship, ancestry, disability, genetic information, military or veteran status, pregnancy, marital or familial status, or any other protected category under applicable law.