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Regulatory Affairs Specialist
3 meses atrás
What We Want
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Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
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Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
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Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
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Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.
What You Will Do
- Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies
- Participates in advocacy activities of a technical and/or tactical nature
- Contact with ANVISA;
- Focused in Regulatory Processes for Brazil
- Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance
- Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions
- Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
- Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
- Evaluates proposed products for regulatory classification and jurisdiction
- Determines requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
- Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
- Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes
- Negotiates with regulatory authorities throughout the product lifecycle
- Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
- Helps train stakeholders on current and new regulatory requirements to ensure organizationwide compliance
- Assists other departments in the development of SOPs to ensure regulatory compliance
- Provides regulatory input and technical guidance on global regulatory requirements to product development teams
- Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations
- Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations
- Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions
- Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships
- Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process
- Provides regulatory information and guidance for proposed product claims/labeling
- Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims
- Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
- Monitors the progress of the regulatory authority review process through appropriate communications with the agency
- Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
- Works with crossfunctional teams for interactions with regulatory authorities including panel meetings and advisory committees
What You Will Need
- Bachelor's in engineering, Science, Pharmaceutical or related degree; or MS in Regulatory Science
- 4+ years of experience in Regulatory Processes for Medical Devices
- Advanced English level is a Must
- Knowledge of orthopedic products is a Plus
- Knowledge of INMETRO Certification
