- Sr Specialist, Regulatory Affairs Puerto Diablo
- Jobleads-Us in Puerto Diablo, Vieques, Puerto Rico
- jobs
- 2 months ago
jobs description
Develop regulatory strategy and submission materials for novel platform approval. Provide internal teams with regulatory guidance, prepare document packages, and ensure compliance with requirements.
Key responsibilities include:
• Representing the regulatory affairs function on cross-functional project teams
• Assisting with regulatory approval of in vitro companion diagnostic medical devices in the US market
• Writing, preparing, editing, and reviewing regulatory submissions to expand indications of marketed products
• Supporting interactions with regulatory agencies, including responses to inspections and submissions
• Reviewing validation protocols and reports for submission soundness
• Publishing electronic regulatory submissions
• Representing the company before regulatory authorities and biopharmaceutical partners
• Providing support for marketed products, including review of engineering changes and labeling
• Supporting change control activities requiring regulatory agency approval
• Acquiring and maintaining knowledge of applicable regulatory requirements and scientific/technical issues
• Drafting submission documents with subject matter experts and reviewing technical documents
Required qualifications include:
• Bachelor's degree and 3+ years of professional experience, or Master's degree and 1+ year of experience
• Direct experience working with the Center for Devices and Radiological Health (CDRH) and writing/submitting pre-sub, IDE application, and PMA documents
• Interpreting scientific data, managing multiple concurrent regulatory submissions, and working cross-functionally on complex projects
• Expertise in regulatory strategy, regulatory compliance knowledge of FDA IVD requirements, and understanding of validation design typical for FDA IVD submissions
• Strong interpersonal skills, including written communication, oral communication, negotiation, collaboration, and problem-solving
• Strong attention to detail and organizational skills, understanding of HIPAA, and commitment to the company's values
Puerto Diablo Vieques Puerto Rico