Regulatory Affairs Specialist

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.

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 FDA Class III implantable medical 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, 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.