RA Project Manager

We are seeking a highly skilled RA Project Manager. In this pivotal role, you will be responsible for managing new product submissions for regulatory approval across diverse markets, including the US, Europe, Japan, China, Brazil, and Australia. Your primary responsibilities will include preparing, coordinating, tracking, and following up on medical device submissions, including 510k and De Novo approvals in the US, EU MDR technical documentation submissions, and regulatory activities in various international markets. You will oversee CER, PMS, and PMCF activities, including handling customer complaints, vigilance, and recalls. You will also participate in regulatory inspections and audits, prepare regulatory assessments for design changes, and develop product labeling in compliance with regulatory requirements.

Qualifications:

Degree in Biomedical Engineering or Biotechnology.

At least 3 years of relevant experience in medical device regulation.

Experience in preparing regulatory submissions (FDA and international submissions)– a must

High level of English proficiency (both written and spoken).

Excellent teamwork and interpersonal skills.

Strong attention to detail.

Proficiency in Microsoft Word, Excel, and PowerPoint.