Sr Regulatory Affairs Specialist

Job Description

We are seeking a highly motivated and detail-oriented Sr. Regulatory Affairs Specialist to join our team. The ideal candidate will play a pivotal role in ensuring our products meet all regulatory standards and achieve timely market access. This role involves collaboration across various departments, providing regulatory guidance, and managing submissions to regulatory bodies.

Key Responsibilities:

• Prepare and submit regulatory documents required for the approval and registration of new and existing products in various markets.
• Stay informed on global regulatory requirements and changes, especially those related to medical devices and surgical sutures, and assess their impact on company products.
• Coordinate with R&D, quality assurance, and other departments to compile necessary documentation for regulatory submissions.
• Advise on regulatory requirements during product development stages.
• Monitor compliance with post-market surveillance and reporting obligations.
• Assist in developing and implementing regulatory strategies to support market entry and expansion.
• Provide regulatory support and guidance to internal teams and external partners.
  
  

Qualifications:

• Bachelor’s degree in a related field (e.g., Biology, Chemistry, Medical Engineering).
• Minimum of 3 years’ experience in regulatory affairs within the medical device industry, particularly with contract manufacturing and surgical sutures.
• Familiarity with FDA, EU MDR, and other international regulatory standards and processes.
• Strong organizational skills with the ability to manage multiple projects simultaneously.
• Excellent written and verbal communication skills.
• Proven ability to think analytically and solve problems efficiently.
  
  

We offer a competitive salary, comprehensive benefits package, and a collaborative work environment focused on professional growth and development. If you are passionate about contributing to the advancement of medical technologies and meet the above criteria, we would love to hear from you.

Company Description

DemeTECH Corporation is a leading manufacturer of medical devices located in Miami Lakes, FL.

DemeTECH Corporation is a leading manufacturer of medical devices located in Miami Lakes, FL.