about 1 year ago
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.