My client is a leading IVD/Diagnostics/Medical Device company that is looking to expand the regulatory team by adding a Manager of Regulatory Affairs.

The Manager of Regulatory Affairs is responsible for acting as the representative for the regulatory team on core cross-functional aspects developing in the preparation of relevant regulatory filings to the FDA and other international registrations/submissions.

Key Responsibilities include:

• Participating on product design teams
• Creating, evaluating, and updating Regulatory Affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
• Reviewing labeling/promotional/advertising materials, and other documents to ensure compliance with applicable regulations
• Maintaining current knowledge of relevant regulations, including proposed and final rules
• Interpreting RA policies and guidance and correctly apply them as regulatory activities
• Developing, managing, and executing regulatory plans for projects, including diagnostics, companion diagnostics, research use only, laboratory use reagents, etc.

Qualifications And Requirements

• BA/BS degree is required. Preferred education/experience include bioengineering, biological, physical, clinical and regulatory sciences. Advanced degrees (MS, MBA, PhD., etc.) a plus
• Previous in vitro diagnostic (IVD) nucleic acid experience, companion diagnostic (CDx), and life science products for translational research experience highly preferred
• 8+ years of (hands on) experience in Regulatory Affairs with FDA regulated products
• Previous experience with 510(k), IDE, and/or PMA submissions
• Working knowledge of FDA QSR and ISO 13485 regulations
• Experience in a Molecular Biology research environment a plus
• Certifications: RAC, CQA, CQM preferred
• Strong interpersonal skills with the ability to influence others in a positive and effective manner
• Strong organizational skills and ability to support multiple projects
• Proven ability to prepare regulatory submissions and interact with FDA to obtain and maintain product approvals
• Proven ability to work on product development teams
• Intellectual curiosity and an ability to digest complex technical data desired
• Experience on guiding cross functional teams bringing products to market from concept, development, verification & validation, clinicals, applicable submissions, clearance/approvals, marketing support for product launch is highly preferred.