Director, Regulatory Affairs

Alveo Technologies is seeking a Director, Regulatory Affairsto develop and execute regulatory strategies to ensure the successful approval and compliance of our IVD products in the global market.In this role, you will combine regulatory, scientific and IVD expertisewith your exceptional skills as a clear and articulate communicator, a great listener, and an observer who can work effectively with other teams across the organization. This role requires a deep understanding of regulatory requirements, leadership skills, and the ability to collaborate effectively with cross-functional teams. 

You will be responsible for:

Regulatory strategy and submissions 

·       Develop and implement comprehensive regulatory strategies for new and existing IVD products 

·       Prepare and submitregulatory filings, including pre-submissions, 510(k)s, and Technical Dossiers 

·       Ensure compliance with US FDA, USDA, EU IVDR and other international regulatory requirements 

Regulatory Compliance 

·       Monitor and interpret regulatory requirements and guidelines to ensure company compliance 

·       Maintain up to date knowledge of regulatory changes and communicate their impact to the organization 

·       Support regulatory inspections and audits, providing necessary documentation and support 

Cross functional Collaboration 

·       Work closely with Research & Development, Quality Assurance, Clinical Affairs, and Commercial Marketing teams to ensure regulatory requirements are met throughout the product development lifecycle 

·       Provide regulatory guidance during product design, development, and validation 

·       Support clinical trial design and execution to meet regulatory standards 

Documentation and Communication 

·       Prepare technical documentation necessary for regulatory submissions 

·       Communicate effectively with regulatory authorities, represent the company in meetings and negotiations 

·       Provide training and support to internal teams on regulatory matters of compliance, requirements, and process 

·       Develop and maintain other technical documentation required for compliance such as policies, SOPs, regulatory content for design history files      

Your background should include:

·       Minimum of a Bachelor's degree in life sciences 

·       Minimum of 10 years previous experience in an in vitro diagnostic or medical device manufacturing organization with a focus on human or animal health 

·       In depth knowledge of regulatory requirements for US, EU, MENA, and other international geographies 

·       Solid understanding of design control requirements 

·       Problem solving skills and the ability to get to yes or no quickly 

·       Excellent communication and teamwork skills, and the ability to adapt and interface effectively with a wide range of stakeholders 

·       Travel 0 - 10% 

Salary range is $196,686 - $205,000 per year