This is a full-time opportunity to join the technical 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.
Position Summary :
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.
Key Responsibilities :
- Develop regulatory strategies for Class III implantable devices, ensuring compliance with applicable regulations and standards.
- Lead the preparation and submission of FDA pre-submission documents, clinical trial protocols, and PMA applications.
- Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents.
- Review and interpret regulatory guidelines, ensuring all submissions meet regulatory requirements.
- Update and maintain authorizations (e.g., IDEs, 510(k)s, Canadian licenses, CE dossiers) and manage renewals, device listings, and site registrations.
- Collaborate with engineering, preclinical, clinical, and quality assurance teams to gather necessary documentation and data for submissions.
- 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)
- Assist in preparing responses to regulatory authorities’ questions within assigned timelines.
- Assess and document regulatory impact of product design changes in jurisdictions where product is licensed.
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
- Maintain quality procedures related to regulatory responsibilities, participate in internal audits, and support post-market surveillance activities.
- Coordinate with external consultants and regulatory agencies as needed. Stay abreast of regulatory procedures, guidance documents, standards, and changes in regulatory climate.
- Maintain up-to-date knowledge of regulatory changes and industry trends.
- Support creation of protocols and supporting documentation for early feasibility studies and clinical trials.
- Experience with packaging regulations and labeling for the final product according to the target jurisdictions.
Education : Minimum of Bachelor’s degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, Pharmacology or related field.
Qualifications :
Minimum 3 years in regulatory affairs and / or quality assurance within a medical device organization.Strong understanding of FDA regulations and guidance documents.Proven experience in preparing IDE, clinical trial, and PMA submissions.Excellent organizational skills and attention to detail.Ability to work independently and as part of a collaborative team.Strong communication and interpersonal skills.Demonstrated ability to digest detailed data while maintaining a view of the big picture.Strong data analysis skills.Excellent written and verbal communication skills with the ability to listen, articulate and advocate.Documented training on current medical device standards and regulations is an asset (e.g. MDSAP, EU MDR, ISO 13485, etc.).Demonstrated skill at managing multiple projects and deadlines.Ability to work effectively in a demanding environment with strict timelines and operating procedures.Additional Attributes :
The incumbent should be proactive and results-oriented with high attention to detail and strong project management and organizational skills.Proficiency in MS Office applications, databases, and efficient online research.