Job Description

About You

You are looking to join a team exploding with growth in a lucrative industry that serves people all over the world. You have a clear understanding of the requirements and approval process for life-changing technology. You build resources and processes where there are none and enjoy paving new roads for innovation. You are a team-builder, quick to adapt, and long-term focused.

About Us

CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries, CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Responsibilities

• Interface with consultants, notified bodies, or health authorities to understand regulatory requirements.
• Lead regulatory and compliance activities and prepare the organization for regulatory responses or submissions.
• Manage Regulatory strategy, and prepare timelines for regulatory approval for both USA and globally.
• Compile and maintain regulatory documentation and database.
• Review and recommend changes for design process and manufacturing procedures to maintain quality and regulatory compliance.
• Review CAPAs, Nonconformance Report, and Complaints and assure quality events are assessed for compliance impact.
• As a Core Team member, coordinate regulatory project activities with cross-functional teams to manage deliverables, timelines, and resources.
• Train cross-functional teams on the regulatory environment and compliance deliverables.
  
  

Required Skills/Abilities

• Knowledge and experienced in US medical device submission requirements.
• Proficient knowledge of medical device regulations 510K
• Strong interpersonal skills with the ability to collaborate closely cross-functional teams.
• Must be detail-oriented and able to multi-task and manage multiple projects.
• Working Experience with a commercial Quality Management System strongly preferred.
• Strong analytical skills, reporting, and data analysis are strong preferred.
• Ability to work in a fast-paced and technically challenging environment where drive is critical to success.
• Knowledge of Class II Medical Devices, and EUA for both COVID-19 and Monkeypox.
  
  

Education And Experience

• M.S./B.A. degree in Molecular Biology, Microbiology, or related science field (an equivalent combination of experience and education may be considered).
• M.S in Regulatory Affairs or RAC [preferred]
• A minimum of 5 years of experience, preferably in medical device or life sciences industry.
• Proven experience and knowledge of FDA quality systems,510K

Benefits

• Health Care Plan (Medical, Dental, & Vision)
• Retirement Plan
• Paid Time Off
• Family Leave
• Training & Development
• Company Sponsored Meals
• Individual and Team Bonding Spending

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