Regulatory Affairs Specialist
3 months ago
- Orchestrates the coordination and preparation of document packages and dossiers for regulatory submissions within and beyond the U.S.
- Actively engages in project teams, contributing regulatory strategy, timelines, and deliverables.
- Manages global regulatory submissions and ongoing responsibilities, ensuring thorough reviews of changes to ensure compliance with new standards.
- Supports the formulation of a global regulatory strategy for post-market changes, encompassing aspects like design, manufacturing, and labeling.
- Assists in GUDID submissions.
- Represents the regulatory function in manufacturing and product development teams, providing regulatory insights for product lifecycle planning. This involves:
- Strategizing and presenting alternatives for meeting regulatory requirements, both within regulatory affairs and cross-functionally.
- Resolving conflicts between regulatory requirements and development issues.
- Escalating complex situations to management for guidance and training opportunities.
- Overseeing documentation packages for submission to global regulatory agencies.
- Tracking timelines and documenting milestone achievements for inclusion in regulatory submissions.
- Assisting in interactions with regulatory agencies, including submission review and on-site audit support (e.g., FDA inspections for future 510(k)s, IVDR audits related to CE marking design dossiers and technical documentation).
- Providing guidance on regulatory requirements essential for contingency planning.
- Monitoring proposed and current global regulations and guidance, assessing their impact on assigned projects, and proposing suggestions for leveraging regulatory updates to expedite the approval process.
- Reviews labeling content, product and process changes, and product documentation to ensure compliance, consistency, and accuracy with regulatory requirements.
- Collaborates with cross-functional teams to define the scope and assess strategies for managing the entire product lifecycle, including pre-market development and post-market changes. Applies design control principles and regulatory knowledge to guide teams through successful regulatory reviews.
- Assists in developing regional regulatory strategy and adapts strategies based on regulatory changes for medical devices.
- Anticipates and navigates regulatory obstacles based on information from international agencies and trends in the regulatory environment.
- Determines and communicates submission and approval requirements, monitoring applications under regulatory review.
- Assists in evaluating proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies.
- Maintains annual licenses, registrations, and listings.
- Assists with document legalization for foreign country registrations.
- Ensures compliance with product post-market approval requirements.
- Reviews regulatory aspects of contracts and assesses external communications relative to regulations.
- Assists with label development and reviews for compliance before release.
- Participates in determining goals and objectives for projects.
- Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
- Assists with required activities and electronic submissions for Medical Devices Reporting (MDR/MDVR), product recalls, field corrective actions, product holds, and health hazard evaluations. Coordinates meetings with the Cross-Functional Team to finalize the decision-making process and follows up to ensure time-sensitive pending tasks are completed accordingly.
- Assists in preparing, reviewing, and maintaining Design History Files (DHFs), Device Master Records (DMRs), Technical Documentation packages (for CE Marking), and other documents and activities for new product development and regulatory submissions.
- Collects, evaluates, and summarizes information for reporting to management to assist with decisions regarding the suitability and effectiveness of the quality management system.
- Plans, coordinates, and prepares a variety of reports, surveys, research information, and special informational requests made by management.
- Participates in the validation of equipment, instruments, facilities, utilities, software, processes, and other validation activities related to regulatory functions.
- Performs special projects and other related duties as assigned by management.
- Bachelors degree in a related field
- RA Certification is preferred but not required
- 3+ years of experience in the med device with 1+ years of Regulatory Affairs experience
- Experience in preparing domestic and international product submissions
- Knowledge and understanding of global regulatory requirements for new products or product changes.
- Knowledge of QSR820, IVD Regulation, ISO 13485, and Design Controls.
- Familiarity with MDSAP (Medical Device Auditing Program) is preferred.
- Experience in leading regulatory document submissions such as e-MDR/Recall, and direct interactions with regulatory agencies.
- Exposure to a broad spectrum of fabrication processes is preferred, including industrial manufacturing, machining, tooling and fixtures, and assembly of electronics and electro-mechanical components.
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