Regulatory Market Access Specialist

This role focuses on ensuring compliance and successful market entry for medical devices. The Regulatory Market Access Specialist will be responsible for navigating regulatory landscapes, preparing submissions, and collaborating with internal teams to facilitate product approvals and commercialization.

Key Responsibilities:

Manage regulatory submissions and interactions with regulatory agencies.
Develop and implement regulatory strategies to support product registrations.
Monitor changes in regulations and assess their impact on product portfolios.
Prepare and review regulatory documentation, ensuring accuracy and completeness.
Collaborate with cross-functional teams, including R&D, quality, and commercial, to ensure regulatory requirements are met.
Provide regulatory guidance and support to internal stakeholders.

Requirements/Qualifications:

Bachelor's degree in a related scientific or regulatory field.
2-7 years of experience in regulatory affairs, preferably in the medical device industry.
Strong understanding of regulatory requirements and processes.
Excellent communication, interpersonal, and organizational skills.
Ability to work independently and as part of a team.
Experience with market access strategies and reimbursement.

About the Company: DJI Global is a leading provider of innovative medical technology solutions. The company is dedicated to developing and delivering products that improve patient outcomes and enhance the quality of life.