Regulatory Affairs Professional

1 week ago

Derwood, Maryland, United States AgNovos Healthcare Full time
Job Opportunity at AgNovos Healthcare

We are seeking a highly organized and detail-oriented Regulatory Affairs Specialist to join our team in Rockville, MD. The successful candidate will be responsible for preparing regulatory submissions, ensuring compliance with EU, US FDA, and other regulatory bodies.

This role involves coordinating with internal teams and external consultants to provide overall regulatory support. Key responsibilities include:

  • Preparing and submitting international regulatory documents (e.g., IDE and PMA) and ensuring accuracy and consistency of submitted materials
  • Maintaining and updating Technical Files and Design Dossiers to ensure compliance with current regulatory standards
  • Coordinating presentations and materials for internal meetings and FDA meetings using Microsoft Office Suite tools

The ideal candidate will have a strong understanding of regulatory requirements and experience working with cross-functional projects. A Bachelor's degree in a science/health-related field and six years of hands-on experience in Regulatory Affairs are required. Additional qualifications include excellent written and oral communication skills, attention to detail, and proficiency in MS Office and Adobe Acrobat.

A competitive annual salary range of $90k-$110k is offered, with final compensation determined based on market analysis, experience, and internal equity. Our comprehensive benefits package includes medical, dental, vision coverage, a 401(k) plan with company match, and a hybrid work schedule with three days per week in the Rockville office.

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