Senior Staff Raqa Specialist Neurovascular

2 meses atrás

Sao Paulo, Brasil Stryker Tempo inteiro

**Who we want**

**Detail-oriented process improvers.** Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.

**Collaborative partners.** People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

**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.

**Curious learners.** People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

**Goal-oriented developers.** Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

**What you will do**

**Regulatory Affairs.**
- 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.
- Evaluates the regulatory environment and contribute 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.
- 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.
- Helps train stakeholders on current and new regulatory requirements to ensure organization-wide 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 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.
- Prioritize, plan, and review product registrations for new products, changes, and renewals of existing registrations and GMP, INMETRO, and/or ANATEL certifications.
- Prepares and submits documentation for GMP Certificate for approval of Health Authority.
- Prepares and submits dossiers of products of Risk Classes (III and IV) for approval of Health Authority.
- 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 cross-functional teams for interactions with regulators including panel meetings and advisory committees.
- Reviews and escalate for further approval labeling (Directions for Use, labels, promotional materials) for compliance with standards, guidelines, regulations, and regulatory approvals/clearances.
- Evaluates, reviews, and responds to Change Notification assessments.
- Tracks the CN impacted to monitor estimated date to receive the documents. Preparing a local regulatory action plan based on the changes and the implementation date expected.
- Maintains the RACM system updated and request the Release form as needed for all countries regulated and unregulated.
- Maintains RA and QA Metrics in PowerBI.
- Processes invoices received from our local consultants in CONCUR platform/JDE and diligence the support needed by the Finance Department.
- Support and control workflow part number inclusion and maintenance in local ERP system.
- Support tender and import operations by timely supply of accurate regulatory documents.
- Establishes relationships with local Medical Device Industry Associations groups and work with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.
- Establishes and maintains a good work

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