Senior Knowledge Specialist, GMA

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.