Our client, in the life science / biotechnology industry, is seeking a contract, remote Director of Regulatory Affairs.

As Director of Regulatory Affairs, you will lead in the design, implementation, and execution of regulatory strategies and processes to obtain and maintain market authorizations that allow the company to legally market our IVD medical products internationally. You will build, manage and lead the Regulatory team that supports the global business expansion strategies of the company.

Core Job Responsibilities

• Develop, lead and manage the Regulatory Team, including the assignment of tasks and responsibilities and timely and effective performance management of staff.
• Lead and manage regulatory registration activities related to the premarket approval of new products, which includes providing guidance for Management, Design Controls, Clinical Evaluations, and decisions on product development activities to ensure regulatory requirements are met internationally.
• Prepare and submit market registration applications for international approvals
• Prepare and submit US premarket submissions such as 510k and EUA applications.
• Support product development teams with regulatory expertise
• Ensures that medical devices are developed according to the state of the art standards and meet requirements of global regulatory authorities, and notified bodies.
• Establish regulatory plans for products to meet global marketing objectives
• Establish regulatory procedures necessary to consistently execute regulatory processes and ensure continual compliance.
• Support the quality management system and review for approval of other quality system documents as applicable.
• Support the evaluation and translation of various complex FDA regulations and ISO standards including ISO 13485, ISO 14971, and applicable harmonized standards into project objectives, deliverables, and activities
• Support global labeling requirements UDI and related systems such as GUDID, EUDAMED, etc. Ensure product labeling and marketing information, adheres to regulatory requirements.

Other Responsibilities

• Performs other duties as required or assigned

Requirements

• Education: B.S. or higher degree in a Life Science, Engineering, or related discipline.

Experience:

1. 8+ years of medical device experience in a regulatory affairs role
   1. 5 years minimum in a regulatory management role
2. Experience in regulatory submittals and applications for medical devices (IVD preferred)
3. Experience in supporting External 3rd Party Audits and Inspections.
4. Experience in molecular biology products or molecular diagnostic products or IVD preferred
5. Excellent organizational, writing, and verbal communication skills.