Regulatory Affairs Professional for Medical Device Development
24 hours ago
Overview:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Fluid Biomed Inc. As a key member of our technical team, you will play a crucial role in the development and commercialization of a novel implantable medical device.
Job Summary:
The Regulatory Affairs Specialist will be responsible for preparing and submitting FDA pre-submissions, Investigational Device Exemptions (IDE), Pivotal Study applications, and Premarket Approval (PMA) submissions for Class III implantable devices. You will develop regulatory strategies, lead document preparation, and collaborate with cross-functional teams to ensure compliance with applicable regulations and standards.
Key Responsibilities:
- Regulatory Strategy Development: Create and implement regulatory strategies for Class III implantable devices, ensuring compliance with FDA regulations and guidance documents.
- Submission Preparation: Lead the preparation and submission of FDA pre-submission documents, clinical trial protocols, and PMA applications.
- Document Writing and Review: Write, analyze, and edit technical documents to support country-specific regulatory submissions, adhering to applicable guidance documents and standards.
- Regulatory Guidelines Review: Review and interpret regulatory guidelines to ensure all submissions meet regulatory requirements.
- Authorization Management: Update and maintain authorizations (e.g., IDEs, 510(k)s, Canadian licenses, CE dossiers) and manage renewals, device listings, and site registrations.
- Team Collaboration: Collaborate with engineering, preclinical, clinical, and quality assurance teams to gather necessary documentation and data for submissions.
- Regulatory Input: Provide regulatory requirement inputs in developing technical and regulatory documents (e.g., SSED as well as verification test methods and protocols).
- Response Preparation: Assist in preparing responses to regulatory authorities' questions within assigned timelines.
- Regulatory Impact Assessment: Assess and document regulatory impact of product design changes in jurisdictions where product is licensed.
- Audit Support: Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
- Quality Procedures: Maintain quality procedures related to regulatory responsibilities, participate in internal audits, and support post-market surveillance activities.
- Consultant Coordination: Coordinate with external consultants and regulatory agencies as needed. Stay abreast of regulatory procedures, guidance documents, standards, and changes in regulatory climate.
- Knowledge Updates: Maintain up-to-date knowledge of regulatory changes and industry trends.
- Protocol Development: Support creation of protocols and supporting documentation for early feasibility studies and clinical trials.
- Packaging Regulations: Experience with packaging regulations and labeling for the final product according to target jurisdictions.
Education and Qualifications:
Minimum of Bachelor's degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, Pharmacology or related field.
Requirements:
- 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.
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.
Salary: $120,000 - $150,000 per annum, depending on experience and qualifications.
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