Sr. Mgr., Regulatory Affairs (RA) & Clinical Affairs

Working Location: Remote 

 

Are you looking for a company that cares about people’s lives and health, including yours? At EVIDENT, we help make people’s lives healthier, safer and more fulfilling, every day. 

 

Let’s inspire healthier lives, together.

We are seeking a detail-oriented and experienced Senior Regulatory Affairs (RA) & Clinical Affairs Manager to join our team. In this critical role, you will act as the FDA US Agent and Official Correspondent, ensuring compliance with FDA regulations and global clinical requirements for our medical device and in vitro diagnostic (IVD) product portfolio. You will manage global clinical affairs, oversee clinical trial activities, and act as the key point of contact for 510(k) submissions and pre-submission discussions with the FDA.

 

This position requires a strong background in regulatory affairs, clinical trial management, and a comprehensive understanding of FDA and global regulatory pathways for medical devices and IVDs.

Clinical Evaluations

• Develop and maintain Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) in compliance with EU MDR/IVDR, FDA, and other global regulatory requirements.
• Conduct systematic literature reviews, post-market clinical follow-ups (PMCF), and risk-benefit analyses to support product lifecycle management.
• Collaborate with cross-functional teams (e.g., R&D, regulatory, quality, and marketing) to gather and analyse clinical evidence.
• Ensure timely updates to clinical documentation to reflect regulatory changes, post-market data, and emerging risks.

 

Clinical Study Management

• Design and oversee clinical study protocols, including feasibility, validation, and performance evaluation studies, to meet regulatory and business objectives.
• Design and oversee clinical study protocols, including feasibility, validation, and performance evaluation studies, to meet regulatory and business objectives.
• Ensure clinical studies comply with Good Clinical Practice (GCP), ISO 14155, and other applicable standards.
• Lead collaborations with clinical research organizations (CROs), laboratories, and external partners to ensure timely and cost-effective study execution.

 

Regulatory Support

• Provide clinical input for regulatory submissions (e.g., 510(k), PMA, CE marking) in alignment with FDA, EU IVDR, and international regulatory requirements.
• Act as the clinical affairs subject matter expert during regulatory audits, inspections, and technical file reviews.
• Collaborate with regulatory teams to address deficiencies or additional information requests related to clinical evidence.

 

Post-Market Surveillance

• Oversee the collection and analysis of post-market data, adverse event reporting, and PMCF studies to ensure continued product compliance and safety.
• Prepare and review periodic safety update reports (PSURs) and summary of safety and performance (SSP) documents.

 

FDA US Agent Official Correspondent

The FDA US Agent is a mandatory role for foreign companies registering with the FDA. This representative acts as the primary point of contact between the FDA and the foreign entity.