Regulatory Affairs Specialist

Job Description

<p>This is a full-time opportunity to join the team of an early-stage company to support the development and commercialization of a novel implantable medical device. Fluid Biomed is an innovative medical device startup focused on developing a cutting-edge neurovascular stent to treat brain aneurysms and enhance patient outcomes worldwide.</p><p><br></p><p><b>Position Summary:</b></p><p>As a Regulatory Affairs Specialist, you will play a crucial role in the preparation and submission of FDA pre-submissions, Investigational Device Exemptions (IDE), Pivotal Study applications, and Premarket Approval (PMA) submissions for Class III implantable devices.</p><p><br></p><p><b>Key Responsibilities:</b></p><ul><li>Develop regulatory strategies for FDA Class III implantable medical devices, ensuring compliance with applicable regulations and standards.</li><li>Lead the preparation and submission of FDA pre-submission documents, clinical trial protocols, and PMA applications.</li><li>Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.</li><li>Review and interpret regulatory guidelines, ensuring all submissions meet regulatory requirements.</li><li>Update and maintain authorizations (e.g., IDEs, Canadian licenses, CE dossiers) and manage renewals, device listings, and site registrations.</li><li>Collaborate with engineering, preclinical, clinical, and quality assurance teams to gather necessary documentation and data for submissions.</li><li>Collaborate with team to provide regulatory requirement inputs in developing technical and regulatory documents (e.g., SSED as well as verification test methods and protocols)</li><li>Assist in preparing responses to regulatory authorities’ questions within assigned timelines.</li><li>Assess and document regulatory impact of product design changes in jurisdictions where product is licensed.</li><li>Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.</li><li>Maintain quality procedures related to regulatory responsibilities, participate in internal audits, and support post-market surveillance activities.</li><li>Coordinate with external consultants and regulatory agencies as needed. Stay abreast of regulatory procedures, guidance documents, standards, and changes in regulatory climate.</li><li>Maintain up-to-date knowledge of regulatory changes and industry trends.</li><li>Support creation of protocols and supporting documentation for early feasibility studies and clinical trials.</li><li>Experience with packaging regulations and labeling for the final product according to the target jurisdictions.</li></ul><p><br></p><p><b>Education: </b>Minimum of<b> </b>Bachelor’s degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, Pharmacology or related field.</p><p><br></p><p><b>Qualifications:</b></p><ul><li>Minimum 3 years in regulatory affairs and/or quality assurance within a medical device organization.</li><li>Strong understanding of FDA regulations and guidance documents.</li><li>Proven experience in preparing IDE, clinical trial, and PMA submissions.</li><li>Excellent organizational skills and attention to detail.</li><li>Ability to work independently and as part of a collaborative team.</li><li>Strong communication and interpersonal skills.</li><li>Demonstrated ability to digest detailed data while maintaining a view of the big picture.</li><li>Strong data analysis skills.</li><li>Excellent written and verbal communication skills with the ability to listen, articulate and advocate.</li><li>Documented training on current medical device standards and regulations is an asset (e.g. MDSAP, EU MDR, ISO 13485, etc.).</li><li>Demonstrated skill at managing multiple projects and deadlines.</li><li>Ability to work effectively in a demanding environment with strict timelines and operating procedures.</li></ul><p><br></p><p><b>Additional Attributes:</b></p><ul><li>The incumbent should be proactive and results-oriented with high attention to detail and strong project management and organizational skills.</li><li>Proficiency in MS Office applications, databases, and efficient online research.</li></ul>