Regulatory Affairs Specialist

Job Description:

We seek an experienced Regulatory Affairs Specialist to join our team and contribute to the company's development, implementation, and management of regulatory processes. The ideal candidate will be responsible for communicating with external regulatory bodies such as Notified bodies, EUDAMED, and authorized representatives. In addition, the candidate will be responsible for analyzing and understanding regulatory requirements, providing guidance to various departments, executing regulatory registrations in multiple regions such as Asia, Europe, North and South America, and ensuring compliance with applicable regulations.

Key Responsibilities:

• Analyze and interpret new regulations in the medical device industry.
• Provide advice and guidance to internal teams on regulatory requirements.
• Develop and implement policies and procedures to meet regulatory standards.
• Conduct risk assessments.
• Represent the company in interactions with regulatory agencies and governmental bodies.
• Prepare reports and reviews on compliance status.
• Performing regulatory registration processes

Requirements:

• Bachelor’s degree in Law, Business Administration, Life Sciences, or a related field.
• Minimum of 3 years of experience in medical device industry regulation.
• Previous submission experience of FDA, EU, and other countries
• In-depth knowledge of regulatory frameworks and compliance requirements.
• Strong analytical skills and strategic thinking ability.
• Excellent interpersonal skills and ability to work collaboratively in a team.
• Proficiency in English
• Willingness to work in unconventional hours

If you are interested in joining a leading team in regulatory affairs, please send your resume to [email protected] with the subject line "Regulatory Affairs Specialist Application."

We look forward to hearing from you!